Instrumed International, Inc.: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.

Agency Publication Date: December 16, 2014

Affected Products

Product: A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.

1) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #1 22.9 mm; CareFusion Item Number: VM29-7112; Lot Numbers: 07211, 100213. 2) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Instrumed Product Number: 310-21113; Trade Name: TeleFlex Medical; Teleflex Medical Product Name: Emmet Tenaculum Hook, #1 22.9 mm; Teleflex Medical Item Number: VM29-7112; Lot Number: 100213. 3) Instrumed Product Name: Emmet Tenaculum Hook, #2, blunt; Instrumed Product Number: 310-21113; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #2, blunt; CareFusion Item Number: VM29-71131X; Lot Number: 110110. 4) Instrumed Product Name : Emmet Tenaculum Hook, #5; Instrumed Product Number: 310-21138; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Emmet Tenaculum Hook, #5; Symmetry Surgical Item Number: 20-4205; Lot Number: 050412. 5) Instrumed Product Name: Emmet Tenaculum Hook, #5; Instrumed Product Number: 310-21138; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #5; CareFusion Item Number: GL804-001; Lot Number: 030313. 6) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; CareFusion Item Number: VM29-7112X; Lot Numbers: 110312, 110411. 7) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm, quick release; Instrumed Product Number: 310-21098; Trade Name: CareFusion; CareFusion Product Name: EMMETT HOOK QUICK RELEASE, NO 1, BLUE RF COATED; CareFusion Item Number: GL805; Lot Numbers: 010214, 020314, 110312.

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Product: An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names.

1) Instrumed Product Name: Novak Biopsy Suct Curette, x-del, 2 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Medline Industries; Medline Industries Product Name: Novak Biopsy Suct Curette, x-del, 2 mm, 9"; Medline Industries Item Number: MDG2480081; Lot Number: 060413. 2) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Medline Industries; Medline Industries Product Name: CURETTE, BIOSPY, NOVAK, 4 MM, 9", 23 CM; Medline Industries Item Number: MDG2480091; Lot Number: 100213. 3) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Boss Instruments; Boss Instruments Product Name: Navak Biopsy SuctCurette, std, 4 mm, 9"; Boss Instruments Item Number: 46-2974; Lot Number: 070512. 4) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Symmetry Surgical Item Number: 52-7050; Lot Numbers: 030412, 070512, 090212, 100213, 120412. 5) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: CareFusion; CareFusion Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; CareFusion Item Number: VM57-3085; Lot Numbers: 050313, 090212, 100213. 6) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Symmetry Surgical Item Number: VM57-3085; Lot Number: 050313. 7) Instrumed Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Instrumed Product Number: 320-05942; Trade Name: Adler Instrument Company; Adler Instrument Company Product Name: Novak Biopsy Suct Curette, std, 4 mm, 9"; Adler Instrument Company Item Number: ADG1750; Lot Number: 100213.

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Product: A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.

1) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medline Industries; Medline Industries Product Name: CLAMP, ZIPSER MEATUS, OVERALL LGTH 4-1/4; Medline Industries Item Number: MDG5597111; Lot Numbers: 051208, 060810. 2) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Boss Instruments; Boss Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Boss Instruments Item Number: 46-5195; Lot Number: 060810. 3) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4"; Millennium Surgical Item Number: 9-124570; Lot Number: 060810. 4) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810. 5) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Medetz Surgical Instruments; Medetz Surgical Instruments Product Name: Zipser Meatus Clamp 4 1/4"; Medetz Surgical Instruments Item Number: 9-124570; Lot Number: 060810. 6) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Zipser Meatus Clamp 4 1/4"; Millennium Surgical Item Number: 9-124570; Lot Numbers: 060810, 080713, 082213. 7) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Surgical Direct; Surgical Direct Product Name: Zipser Meatus Clamp 4 1/4"; Surgical Direct Item Number: SD16450.100; Lot Number: 060810. 8) Instrumed Product Name: Zipser Meatus Clamp 4 1/4"; Instrumed Product Number: 330-86112; Trade Name: Surgipro; Surgipro Product Name: Zipser Meatus Clamp 4 1/4"; Surgipro Item Number: SPGU-4570; Lot Number: 060810.

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Product: A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.

1) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number: 500-01938; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, lg, 12 mm; Symmetry Surgical Item Number: 54-7004; Lot Numbers: 050213, 100410. 2) Instrumed Product Name: Nelson Patterson Trocar, lg, 12 mm; Instrumed Product Number: 500-01938; Trade Name: CareFusion; CareFusion Product Name: Nelson Patterson Trocar, lg, 12 mm; CareFusion Item Number: VM72-3111; Lot Number: 050213. 3) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Instrumed Product Number: 500-01943; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Symmetry Surgical Item Number: 54-7005; Lot Number: 060312. 4) Instrumed Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Instrumed Product Number: 500-01943; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Nelson Patterson Trocar, med-lg, 10 mm; Ambler Surgical Item Number: 95-203; Lot Number: 100410. 5) Instrumed Product Name: Nelson Patterson Trocar, med, 1.5 mm; Instrumed Product Number: 500-01948; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, med, 1.5 mm; Symmetry Surgical Item Number: 54-7006; Lot Number: 100410. 6) Instrumed Product Name: Nelson Patterson Trocar, sm, 6.0 mm; Instrumed Product Number: 500-01953; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Nelson Patterson Trocar, sm, 6.0 mm; Symmetry Surgical Item Number: 54-7007; Lot Number: 030312.

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Product: An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Medline Industries, Medsaver M S I Precision, and Surgical Direct brand names.

1) Instrumed Product Name: Valvulotome 6 1/4" Retrograde; Instrumed Product Number: 500-05626; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome 6 1/4" Retrograde; Symmetry Surgical Item Number: 55-8685; Lot Numbers: 030412, 060413, 070513. 2) Instrumed Product Name: Valvulotome 6 1/4" Retrograde; Instrumed Product Number: 500-05626; Trade Name: CareFusion; CareFusion Product Name: Valvulotome 6 1/4" Retrograde; CareFusion Item Number: 55-8685; Lot Number: 070513. 3) Instrumed Product Name: Valvulotome 6 1/4" Retrograde; Instrumed Product Number: 500-05626; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, retro, 6 1/4"; Boss Instruments Item Number: 65-7048; Lot Numbers: 030412, 060413, 070513, 110411. 4) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle; Phoenix Instruments Item Number: 155-8680; Lot Numbers: 020114, 050114, 060112, 120312. 5) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Autobahn Surgical; Autobahn Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle; Autobahn Surgical Item Number: 352614A; Lot Number: 120312. 6) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Echo Instruments; Echo Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle; Echo Instruments Item Number: 558-690; Lot Number: 070513. 7) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle; Symmetry Surgical Item Number: 155-8680; Lot Numbers: 020114, 030314, 050114, 060112, 060214, 070513, 110212, 120312. 8) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle; Millennium Surgical Item Number: 9-68680; Lot Numbers: 030314, 070513, 120312. 9) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: B.B.M. Surgical Instruments; B.B.M. Surgical Instruments Product Name: Valvulotome, retro, 9 1/4" reverse angle; B.B.M. Surgical Instruments Item Number: BBM8680; Lot Number: 060112. 10) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Valvulotome, retro, 9 1/4" reverse angle; Stealth Surgical Item Number: SSV21161; Lot Numbers: 040513, 050114, 060112, 070513, 120312. 11) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: CareFusion; CareFusion Product Name: Valvulotome, retro, 9 1/4" reverse angle; CareFusion Item Number: VM76-8161; Lot Numbers: 020114, 030314, 050114, 070513, 110212, 120312. 12) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, retro, 9 1/4"; Boss Instruments Item Number: 65-7050 ; Lot Numbers: 050214, 060112, 060214. 13) Instrumed Product Name: Valvulotome, retro, 9 1/4" reverse angle; Instrumed Product Number: 500-05631; Trade Name: Medline Industries; Medline Industries Product Name: VALVULOTOME, LEATHER, ANTEGRADE, 2.9 TIP 9.5"; Medline Industries Item Number: MDG0416536; Lot Number: 070513. 14) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome, retro, 12" cut edge 2 mm; Phoenix Instruments Item Number: 155-8682; Lot Number: 070212. 15) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Autobahn Surgical; Autobahn Surgical Product Name: Valvulotome, retro, 12" cut edge 2 mm; Autobahn Surgical Item Number: 352613A; Lot Number: 070212. 16) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Medsaver M S I Precision; Medsaver M S I Precision Product Name: Valvulotome, retro, 12" cut edge 2 mm; Medsaver M S I Precision Item Number: 421637J; Lot Number: 110212. 17) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome, retro, 12" cut edge 2 mm; Symmetry Surgical Item Number: 55-8682; Lot Numbers: 020413, 030314, 050114, 060413, 070212, 100313, 110212. 18) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Surgical Direct; Surgical Direct Product Name: Valvulotome, retro, 12" cut edge 2 mm; Surgical Direct Item Number: 9-68680001; Lot Numbers: 060413, 100313. 19) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Valvulotome, retro, 12" cut edge 2 mm; Millennium Surgical Item Number: SD8121.103; Lot Numbers: 050114, 060413. 20) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: CareFusion; CareFusion Product Name: Valvulotome, retro, 12" cut edge 2 mm; CareFusion Item Number: VM76-8163; Lot Numbers: 020413, 030314, 050114, 060413, 070212, 080111, 100313, 110212. 21) Instrumed Product Name: Valvulotome, retro, 12" cut edge 2 mm; Instrumed Product Number: 500-05636; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, retro, 12"; Boss Instruments Item Number: 65-7052; Lot Numbers: 050114, 060413. 22) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome, ante, 6 1/4"; Phoenix Instruments Item Number: 155-8681; Lot Number: 080111. 23) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome, ante, 6 1/4"; Symmetry Surgical Item Number: 55-8681; Lot Numbers: 030314, 040214, 060413, 070212, 080111, 120413. 24) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Valvulotome, ante, 6 1/4"; Millennium Surgical Item Number: 9-68681; Lot Numbers: 040214, 060413. 25) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: B.B.M. Surgical Instruments; B.B.M. Surgical Instruments Product Name: Valvulotome, ante, 6 1/4"; B.B.M. Surgical Instruments Item Number: BBM8681; Lot Number: 050312. 26) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Valvulotome, ante, 6 1/4"; Stealth Surgical Item Number: SSV21162; Lot Numbers: 060413, 070212. 27) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: CareFusion; CareFusion Product Name: Valvulotome, ante, 6 1/4"; CareFusion Item Number: VM76-8162; Lot Numbers: 030314, 040214, 060413, 120413. 28) Instrumed Product Name: Valvulotome, ante, 6 1/4"; Instrumed Product Number: 500-05656; Trade Name: Medline Industries; Medline Industries Product Name: Valvulotome, ante, 6 1/4"; Medline Industries Item Number: MDG546940; Lot Number: 060413. 29) Instrumed Product Name: Valvulotome, ante, 7"; Instrumed Product Number: 500-05660; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, ante, 7"; Boss Instruments Item Number: 65-7051-7; Lot Numbers: 050314, 100313. 30) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: Autobahn Surgical; Autobahn Surgical Product Name: Valvulotome 9 1/4" Antegrade; Autobahn Surgical Item Number: 352612A; Lot Number: 090412. 31) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome 9 1/4" Antegrade; Symmetry Surgical Item Number: 55-8684; Lot Numbers: 020311, 070513, 090412. 32) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: CareFusion; CareFusion Product Name: Valvulotome 9 1/4" Antegrade; CareFusion Item Number: VM76-8150; Lot Numbers: 070513, 090412, 100513. 33) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome, ante, 9 1/4"; Boss Instruments Item Number: 65-7049; Lot Number: 070513. 34) Instrumed Product Name: Valvulotome 9 1/4" Antegrade; Instrumed Product Number: 500-05664; Trade Name: Medline Industries; Medline Industries Product Name: Valvulotome, Antegrade 9 1/4" ; Medline Industries Item Number: MDG0416566; Lot Number: 090412. 35) Instrumed Product Name: Valvulotome Antegrade, 12"; Instrumed Product Number: 500-05669; Trade Name: Boss Instruments; Boss Instruments Product Name: Valvulotome Antegrade, 12" ; Boss Instruments Item Number: 65-7053; Lot Numbers: 020114, 050114, 050312, 060413, 090412. 36) Instrumed Product Name: Valvulotome Antegrade, 12"; Instrumed Product Number: 500-05669; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Valvulotome Antegrade, 12" ; Phoenix Instruments Item Number: 155-8683; Lot Number: 060413. 37) Instrumed Product Name: Valvulotome Antegrade, 12"; Instrumed Product Number: 500-05669; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Valvulotome Antegrade, 12" ; Symmetry Surgical Item Number: 55-8683; Lot Number: 020114, 050312, 060413.

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Product: Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.

1) Instrumed Product Name: Bunnell Drill, 5 3/4", w/ chuck key; Instrumed Product Number: 590-05389; Trade Name: Boss Instruments; Boss Instruments Product Name: Bunnell Drill, 5 3/4"; Boss Instruments Item Number: 74-1240; Lot Numbers: 030511, 060110, 070311.

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Product: A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names.

1) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Teleflex Medical; Teleflex Medical Product Name: CLAMP MOGEN; Teleflex Medical Item Number: P-16310; Lot Numbers: 010214, 030113, 050114, 060313, 100112. 2) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Boss Instruments; Boss Instruments Product Name: Mogan Circumcision Clamp, infant; Boss Instruments Item Number: 46-5190; Lot Numbers: 030113, 100112. 3) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Mogan Circumcision Clamp, infant; Millennium Surgical Item Number: 0-64227; Lot Numbers: 010214, 030112, 030113, 100112, 120413. 4) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Mogan Circumcision Clamp, infant; Phoenix Instruments Item Number: 185-6550; Lot Number: 080111. 5) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Mogan Circumcision Clamp, infant; Symmetry Surgical Item Number: 85-6550; Lot Numbers: 010214, 020411, 030112, 030113, 050114, 060313, 100112, 120111, 120413. 6) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: GICAL; GICAL Product Name: Mogan Circumcision Clamp, infant; GICAL Item Number: H156-7312; Lot Numbers: 010214, 030113. 7) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: CareFusion; CareFusion Product Name: Mogan Circumcision Clamp, infant; CareFusion Item Number: VM57-6201; Lot Numbers: 010214, 030113, 050114, 080111, 100112. 8) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Teleflex Medical; Teleflex MedicalProduct Name: Mogan Circumcision Clamp, infant; Teleflex MedicalItem Number: P-16310; Lot Number: 120111.

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Product: Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.

1) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed Product Number: 590-06491; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Millennium Surgical Item Number: 0-48239; Lot Numbers: 020212, 120312. 2) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed Product Number: 590-06491; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Symmetry Surgical Item Number: 57-6305; Lot Numbers: 020212, 100111, 100213, 120312. 3) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed Product Number: 590-06491; Trade Name: Medline Industries; Medline Industries Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Medline Industries Item Number: MDG1806301; Lot Numbers: 020212, 100111. 4) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed Product Number: 590-06491; Trade Name: CareFusion; CareFusion Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; CareFusion Item Number: VM85-1261; Lot Number: 100111. 5) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed Product Number: 590-06491; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Boss Instruments Item Number: 74-0150; Lot Numbers: 020212, 120312. 6) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Instrumed Product Number: 590-06491; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4", shaft, 3/16" OD; Boss Instruments Item Number: 74-0150; Lot Numbers: 020212, 120312. 7) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Instrumed Product Number: 590-06496; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Millennium Surgical Item Number: 0-48240; Lot Numbers: 010312, 090113, 120312. 8) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Instrumed Product Number: 590-06496; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Symmetry Surgical Item Number: 57-6306; Lot Numbers: 010312, 090113, 120312. 9) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Instrumed Product Number: 590-06496; Trade Name: Medline Industries; Medline Industries Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Medline Industries Item Number: MDG1806306; Lot Number: 010312. 10) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Instrumed Product Number: 590-06496; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4", shaft, 7/32" OD; Boss Instruments Item Number: 74-0152; Lot Numbers: 010312, 120312. 11) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Instrumed Product Number: 590-06501; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Millennium Surgical Item Number: 74-0152; Lot Numbers: 060213, 090411, 110412, 120312. 12) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Instrumed Product Number: 590-06501; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Symmetry Surgical Item Number: 57-6309; Lot Numbers: 060213, 090411, 110412, 120312. 13) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Instrumed Product Number: 590-06501; Trade Name: Medline Industries; Medline Industries Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Medline Industries Item Number: MDG1884299; Lot Numbers: 090411. 14) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Instrumed Product Number: 590-06501; Trade Name: Surgical Direct; Surgical Direct Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Surgical Direct Item Number: SD145691.102; Lot Numbers: 060213, 120312. 15) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Instrumed Product Number: 590-06501; Trade Name: CareFusion; CareFusion Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; CareFusion Item Number: VM85-1265; Lot Number: 090411. 16) Instrumed Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Instrumed Product Number: 590-06501; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine, 6 1/4", shaft, 5/16" OD; Boss Instruments Item Number: 74-0154; Lot Numbers: 060213, 090411, 110412, 120312. 17) Instrumed Product Name: Michele Trephine 10", customer over all length, 4.8 mm OD; Instrumed Product Number: 590-06506; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine 10", customer over all length, 4.8 mm OD; Boss Instruments Item Number: 74-0155; Lot Number: 090411. 18) Instrumed Product Name: Michele Trephine 10", customer over all length, 5.5 mm OD; Instrumed Product Number: 590-06506; Trade Name: Boss Instruments; Boss Instruments Product Name: Michele Trephine 10", customer over all length, 5.5 mm OD; Boss Instruments Item Number: 74-0156; Lot Number: 020213, 030111.

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Product: Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names.

1) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Telelfex Medical; Telelfex Medical Product Name: Hudson Brace, snap lock chuck; Telelfex Medical Item Number: P-22880; Lot Number: 110212. 2) Instrumed Product Name: Hudson Brace, snap lock chuck; Instrumed Product Number: 600-00479; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Brace, snap lock chuck; Boss Instruments Item Number: 74-0121; Lot Number: 110212. 3) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Brace Only; Symmetry Surgical Item Number: 57-6004; Lot Number: 060414. 4) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Teleflex Medical; Teleflex Medical Product Name: Hudson Brace Only; Teleflex Medical Item Number: P-22881; Lot Number: 100211. 5) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: CareFusion; CareFusion Product Name: Hudson Brace Only; CareFusion Item Number: VM85-1233; Lot Number: 100211. 6) Instrumed Product Name: Hudson Brace Only; Instrumed Product Number: 600-00484; Trade Name: Boss Instruments; v Product Name: Hudson Brace Only with Tumb Screw Lock; Boss Instruments Item Number: 74-0122; Lot Number: 100211.

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Product: Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name.

1) Instrumed Product Name: Hudson Cerebellar Extension; Instrumed Product Number: 600-00499; Trade Name: Boss Industries; Boss Industries Product Name: Hudson Cerebellar Extension; Boss Industries Item Number: 74-0132; Lot Number: 110411.

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Product: Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names.

1) Instrumed Product Name: Cushing Perforating, Drill, 3/8", 10 mm; Instrumed Product Number: 600-00509; Trade Name: Boss Industries; Boss Industries Product Name: Cushing Perforating, Drill, 3/8", 10 mm; Boss Industries Item Number: 74-0100; Lot Number: 110211. 2) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Instrumed Product Number: 600-00514; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Symmetry Surgical Item Number: 57-6034; Lot Number: 060212. 3) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Instrumed Product Number: 600-00514; Trade Name: Medfix International; Medfix International Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Medfix International Item Number: MF223-1577; Lot Number: 060212. 4) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Instrumed Product Number: 600-00514; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Stealth Surgical Item Number: SS2122; Lot Number: 060212. 5) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Instrumed Product Number: 600-00514; Trade Name: CareFusion; CareFusion Product Name: Cushing Perforating, Drill, 1/2", 13 mm; CareFusion Item Number: VM85-1213; Lot Number: 060212, 110313.

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Product: Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.

1) Instrumed Product Name: Cushing Burr, 3/8", 10 mm; Instrumed Product Number: 600-00529; Trade Name: Medfix International; Medfix International Product Name: Cushing Burr, 3/8", 10 mm; Medfix International Item Number: MF223-1592; Lot Number: 060311. 2) Instrumed Product Name: Cushing Burr, 5/8", 16 mm; Instrumed Product Number: 600-00534; Trade Name: Medfix International; Medfix International Product Name: Cushing Burr, 5/8", 16 mm; Medfix International Item Number: MF223-1597; Lot Number: 060311. 3) Instrumed Product Name: Cushing Burr, 3/4", 20 mm; Instrumed Product Number: 600-00539; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Cushing Burr, 3/4", 20 mm; Stealth Surgical Item Number: SS2133; Lot Number: 060311.

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Product: Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries brand names.

1) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Burr, 9 mm; Symmetry Surgical Item Number: 57-6009; Lot Number: 030211. 2) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Medfix International; Medfix International Product Name: Hudson Burr, 9 mm; Medfix International Item Number: MF223-1612; Lot Number: 060410. 3) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 9 mm; CareFusion Item Number: VM85-1235; Lot Number: 030211. 4) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 9 mm; Boss Instruments Item Number: 74-0124; Lot Number: 060410. 5) Instrumed Product Name: Hudson Burr, 10 mm; Instrumed Product Number: 600-00553; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 10 mm; Boss Instruments Item Number: 74-0125; Lot Number: 030305. 6) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 14 mm; CareFusion Item Number: H-0343; Lot Numbers: 110212, 120313. 7) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: Medline Industries; Medline Industries Product Name: Hudson Burr, 14 mm; Medline Industries Item Number: MDG1199404; Lot Number: 030213. 8) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 14 mm; Boss Instruments Item Number: 74-0126; Lot Number: 120313. 9) Instrumed Product Name: Hudson Burr, 16 mm; Instrumed Product Number: 600-00566; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 16 mm; Boss Instruments Item Number: 74-0128; Lot Number: 110111. 10) Instrumed Product Name: Hudson Burr, 22 mm; Instrumed Product Number: 600-00571; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 22 mm; CareFusion Item Number: VM85-1241; Lot Number: 110212. 11) Instrumed Product Name: Hudson Burr, 22 mm; Instrumed Product Number: 600-00571; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 22 mm; Boss Instruments Item Number: 74-0130; Lot Number: 110212. 12) Instrumed Product Name: Hudson Burr, 16 mm; Instrumed Product Number: 606-00566; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 16 mm; CareFusion Item Number: VM85-12391; Lot Number: 050108.

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Product: McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.

1) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: McKenzie Perforator Drill, 13 mm; Phoenix Instruments Item Number: 157-6043; Lot Number: 070412. 2) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Stealth Surgical; Stealth Surgical Product Name: McKenzie Perforator Drill, 13 mm; Stealth Surgical Item Number: SS2151; Lot Number: 070412. 3) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: CareFusion; CareFusion Product Name: McKenzie Perforator Drill, 13 mm; CareFusion Item Number: VM85-1235; Lot Number: 030211. 4) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: CareFusion; CareFusion Product Name: McKenzie Perforator Drill, 13 mm; CareFusion Item Number: VM85-1251; Lot Number: 050111. 5) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Boss Instruments; Boss Instruments Product Name: McKenzie Perforator Drill, 13 mm; Boss Instruments Item Number: 74-0140; Lot Number: 070412.

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Product: D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names.

1) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: D'errico Perforator Drill, 16 mm; Symmetry Surgical Item Number: 57-6076; Lot Number: 110211. 2) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: Teleflex Medical; Teleflex Medical Product Name: D'errico Perforator Drill, 16 mm; Teleflex Medical Item Number: P-22893; Lot Number: 110211. 3) Instrumed Product Name: D'errico Perforator Drill, 16 mm; Instrumed Product Number: 600-00601; Trade Name: CareFusion; CareFusion Product Name: D'errico Perforator Drill, 16 mm; CareFusion Item Number: VM85-1253.

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Product: McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.

1) Instrumed Product Name: McKenzie Enlarging Burr; Instrumed Product Number: 600-00606; Trade Name: CareFusion; CareFusion Product Name: McKenzie Enlarging Burr; CareFusion Item Number: VM85-1255; Lot Number: 030411. 2) Instrumed Product Name: McKenzie Enlarging Burr; Instrumed Product Number: 600-00606; Trade Name: Boss Instruments; Boss Instruments Product Name: McKenzie Enlarging Burr; Boss InstrumentsItem Number: 74-0144; Lot Number: 060311.

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Product: Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names.

1) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Symmetry Surgical Item Number: 57-6000; Lot Number: 110212. 2) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Medfix International; Medfix International Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Medfix International Item Number: MF223-1672; Lot Number: 110212. 3) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Stealth Surgical Item Number: SS2135; Lot Number: 110212. 4) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Boss Instruments Item Number: 74-0120; Lot Numbers: 030112, 110212.

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Product: Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.

1) Instrumed Product Name: Galt Trephine, 5/8"; Instrumed Product Number: 600-01091; Trade Name: CareFusion; CareFusion Product Name: Galt Trephine, 5/8"; CareFusion Item Number: VM85-1273; Lot Number: 120411.

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Product: Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names.

1) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Millenium Surgical; Millenium Surgical Product Name: Gardner-Wells Traction Tongs Complete; Millenium Surgical Item Number: 12-661025; Lot Numbers: 040313, 070512. 2) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Echo Instruments; Echo Instruments Product Name: Gardner-Wells Traction Tongs Complete; Echo Instruments Item Number: 576-804; Lot Numbers: 050413, 110212. 3) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Millenium Surgical; Millenium Surgical Product Name: Gardner-Wells Traction Tongs Complete; Millenium Surgical Item Number: 6-1945; Lot Numbers: 030314, 040313, 050413, 110212. 4) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Adler Instrument; Adler Instrument Product Name: Gardner-Wells Traction Tongs Complete; Adler Instrument Item Number: ADR1945; Lot Number: 050413. 5) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Surgical Direct; Surgical Direct Product Name: Gardner-Wells Traction Tongs Complete; Surgical Direct Item Number: SD5861.100; Lot Number: 050413. 6) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardner-Wells Traction Tongs Complete; Stealth Surgical Item Number: SS2191; Lot Number: 110212. 7) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Traction Tongs Complete; CareFusion Item Number: VM85-1291; Lot Numbers: 030314, 040313, 050413, 050512, 070212, 070512, 110212. 8) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Traction Tongs Set; CareFusion Item Number: NL9500; Lot Numbers: 030314, 040313, 050413, 050512, 050514, 060514, 070212, 110212. 9) Instrumed Product Name: Gardner-Wells Traction Tongs Complete; Instrumed Product Number: 630-05401; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardner-Wells Traction Tongs Complete; Boss InstrumentsItem Number: 74-0180; Lot Numbers: 030314, 040313, 050413, 070512. 10) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Instrumed Product Number: 638-05401; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Symmetry Surgical Item Number: 57-6804T; Lot Number: 070512. 11) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Instrumed Product Number: 638-05401; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Millennium Surgical Item Number: 6-1944; Lot Numbers: 060413, 070512, 100211. 12) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Instrumed Product Number: 638-05401; Trade Name: Adler Instrument; Adler Instrument Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Adler Instrument Item Number: ADR1944; Lot Number: 110312. 13) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Instrumed Product Number: 638-05401; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; CareFusion Item Number: VM85-12915; Lot Numbers: 020411, 050412, 070512, 100211. 14) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Instrumed Product Number: 638-05401; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Traction Tongs, Small Opening 7" (17.8 CM); CareFusion Item Number: NL9510-T; Lot Numbers: 060413, 070512, 100211, 110312. 15) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Small 7" Opening; Instrumed Product Number: 638-05401; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardner-Wells Traction Tongs, Complete; Boss Instruments Item Number: 74-0180T; Lot Numbers: 070512, 110312. 16) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Medium 7 1/2" Opening; Instrumed Product Number: 638-05433; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Gardner-Wells Traction Tongs, Medium 7 1/2" Opening; Symmetry Surgical Item Number: 57-6803T; Lot Numbers: 050412, 110312. 17) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Medium 7 1/2" Opening; Instrumed Product Number: 638-05433; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardner-Wells Traction Tongs, Medium 7 1/2" Opening; Millennium Surgical Item Number: 6-1944MD; Lot Numbers: 070512, 110312. 18) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Medium 7 1/2" Opening; Instrumed Product Number: 638-05433; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardner-Wells Traction Tongs, Medium 7 1/2" Opening; Boss Instruments Item Number: 74-0186T; Lot Numbers: 070512, 100112, 100211, 100212. 19) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Medium 7 1/2" Opening; Instrumed Product Number: 638-05433; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardner-Wells Traction Tongs, Medium 7 1/2" Opening; Stealth Surgical Item Number: SS2197T; Lot Number: 100112. 20) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Medium 7 1/2" Opening; Instrumed Product Number: 638-05433; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Traction Tongs, Medium 7 1/2" Opening; CareFusion Item Number: VM85-12975; Lot Number: 050412, 100211. 21) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Medium 7 1/2" Opening; Instrumed Product Number: 638-05433; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Traction Tongs, Medium Opening 7-1/2" (19 CM); CareFusion Item Number: NL9511-T; Lot Number: 070512. 22) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Large 8" Opening; Instrumed Product Number: 638-05437; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardner-Wells Titanium Traction Tongs, Large 8" Opening; Millennium Surgical Item Number: 6-1944LG; Lot Number: 050413. 23) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Large 8" Opening; Instrumed Product Number: 638-05437; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardner-Wells Titanium Traction Tongs, Large 8" Opening; Boss Instruments Item Number: 74-0188T; Lot Numbers: 020512, 040114, 050412, 050413, 070512, 100212. 24) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Large 8" Opening; Instrumed Product Number: 638-05437; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardner-Wells Titanium Traction Tongs, Large 8" Opening; Stealth Surgical Item Number: SS2198T; Lot Numbers: 040114, 050413, 070512. 25) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Large 8" Opening; Instrumed Product Number: 638-05437; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Traction Tongs, Large 8" Opening; CareFusion Item Number: VM85-12995; Lot Numbers: 020512, 100212, 120413. 26) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Large 8" Opening; Instrumed Product Number: 638-05437; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Traction Tongs, Large 8" Opening; CareFusion Item Number: VM85-12995; Lot Numbers: 020512, 100212, 120413. 27) Instrumed Product Name: Gardner-Wells Traction Tongs Titanium Large 8" Opening; Instrumed Product Number: 638-05437; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Traction Tongs, Large 8" Opening (20.3 CM); CareFusion Item Number: NL9512-T; Lot Numbers: 020512, 040114, 050412, 050413, 070213, 120413.

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Product: Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical brand names.

1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Fixation Screws Fixation Screw Non-Springloaded; CareFusion Item Number: NL9506; Lot Numbers: 010113, 020512, 050514, 060213, 070213, 070413, 120413. 2) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Boss Instruments; Boss Instruments Product Name: Replacement Screw Non-Springloaded for 74-0180; Boss Instruments Item Number: 74-0185; Lot Numbers: 010113, 020512, 060213, 120413. 3) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Millennium Surgical Item Number: 6-1948; Lot Numbers: 020512, 070213, 120413. 4) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Prezio Health; Prezio Health Product Name: Replacement Screw Non-Springloaded, Traction Tong; Prezio Health Item Number: 85-1296; Lot Number: 020512. 5) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Stealth Surgical Item Number: SS2193B; Lot Numbers: 020512, 120413. 6) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: CareFusion; CareFusion Product Name: Replacement Screw Non-Springloaded, Traction Tong; CareFusion Item Number: VM85-1296; Lot Numbers: 010113, 010412, 020512.

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Product: Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names

1) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Fixation Screw, Springloaded; CareFusion Item Number: NL9513-T; Lot Number: 012412. 2) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion Item Number: NL9515-T; Lot Number: 012412. 3) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Millennium Surgical Item Number: 6-1944LN; Lot Number: 012412. 4) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Boss Instruments; Boss Instruments Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Boss Instruments Item Number: 74-0181T; Lot Number: 012412. 5) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; Stealth Surgical Item Number: SS2195T; Lot Number: 012412. 6) Instrumed Product Name: Lock Nut for Titanium Traction Tongs; Instrumed Product Number: 638-05409; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Titanium Traction Tongs Lock Nut; CareFusion Item Number: VM85-12925; Lot Number: 012412.

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Product: Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand names.

1) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Titanium Fixation Screw Springloaded, Each; Millennium Surgical Item Number: 6-1944TS; Lot Numbers: 100512, 110313. 2) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Boss Instruments; Boss Instruments Product Name: Titanium Fixation Screw Springloaded, Each; Boss Instruments Item Number: 74-0184T; Lot Numbers: 020512, 100512. 3) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Titanium Fixation Screw Springloaded, Each; Stealth Surgical Item Number: SS2193AT; Lot Number: 020512. 4) Instrumed Product Name: Titanium Fixation Screw Springloaded, Each; Instrumed Product Number: 638-05421; Trade Name: CareFusion; CareFusion Product Name: Titanium Fixation Screw Springloaded, Each; CareFusion Item Number: VM85-12955; Lot Number: 050314, 110211, 110313.

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Product: Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names.

1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Fixation Screw Non-Springloaded; CareFusion Item Number: NL9514-T; Lot Number: 100512. 2) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: Boss Instruments; Boss Instruments Product Name: Replacement Screw Non-Springloaded, Traction Tong; Boss Instruments Item Number: 74-0185T; Lot Numbers: 020512, 100512, 110211. 3) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Stealth Surgical Item Number: SS2193BT; Lot Numbers: 070312. 4) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: CareFusion; CareFusion Product Name: Replacement Screw Non-Springloaded, Traction Tong; CareFusion Item Number: VM85-12965; Lot Numbers: 100512, 110211.

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Product: Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name.

1) Instrumed Product Name: Gardner-Wells Titanium Wrench 1/2"; Instrumed Product Number: 638-05441; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Wrench 1/2"; CareFusion Item Number: VM85-12015; Lot Number: 011112. 2) Instrumed Product Name: Gardner-Wells Titanium Wrench 1/2"; Instrumed Product Number: 638-05441; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Wrench 1/2"; CareFusion Item Number: NL9516-T; Lot Number: 011112.

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Product: CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Teleflex Medical brand names.

1) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5106; Lot Number: 090109. 2) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Millennium Surgical Item Number: 57-5106; Lot Number: 090109. 3) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Medfix International Item Number: MF232-9052; Lot Numbers: 050214, 090109, 1290018. 4) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; CareFusion Item Number: VM84-3602; Lot Numbers: 090109. 5) Instrumed Product Name: CVB Distraction Screw, 12 mm, Non-Sterile; Instrumed Product Number: 650-11438; Trade Name: Boss Instruments; Boss Instruments Product Name: CVB Distraction Screw, pkg 5, 12 mm, Non-Sterile; Boss Instruments Item Number: 73-2591; Lot Numbers: 090109. 6) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5107; Lot Numbers: 020313, 090209. 7) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Millennium Surgical Item Number: 6-2878; Lot Numbers: 070109, 090109, 090209. 8) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Medline Industries; Medline Industries Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Medline Industries Item Number: MDG1108066; Lot Numbers: 020313, 090209. 9) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Medfix International Item Number: MF232-9057; Lot Numbers: 020313, 050214, 090209. 10) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Surgical Direct; Surgical Direct Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Surgical Direct Item Number: SD145691.103; Lot Number: 090209. 11) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; CareFusion Item Number: VM84-3603; Lot Numbers: 020313, 090209. 12) Instrumed Product Name: CVB Distraction Screw, 14 mm, Non-Sterile; Instrumed Product Number: 650-11454; Trade Name: Teleflex Medical; Teleflex Medical Product Name: Distraction Screw CVD 14 mm; Teleflex Medical Item Number: P-22488; Lot Number: 090209. 13) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Symmetry Surgical Item Number: 57-5108; Lot Numbers: 010114, 120408. 14) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Millennium Surgical; Millennium Surgical Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Millennium Surgical Item Number: 6-2879; Lot Number: 120408. 15) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: Medfix International; Medfix International Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Medfix International Item Number: MF232-9062; Lot Number: 120408. 16) Instrumed Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; Instrumed Product Number: 650-11470; Trade Name: CareFusion; CareFusion Product Name: CVB Distraction Screw, 16 mm, Non-Sterile; CareFusion Item Number: VM84-3604; Lot Number: 120408. 17) Instrumed Product Name: CVB Distraction Screw, 18 mm, Non-Sterile; Instrumed Product Number: 650-11486; Trade Name: Symmetry Surgical; Symmetry SurgicalProduct Name: CVB Distraction Screw, 18 mm, Non-Sterile; Symmetry SurgicalItem Number: 57-5100; Lot Numbers: 040109, 121610.

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Product: Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.

1) Instrumed Product Name: Cloward Spanner Gauge, Small 5 1/8"; Instrumed Product Number: 650-11864; Trade Name: Boss Instruments; Boss Instruments Product Name: Cloward Spanner Gauge, Small 5 1/8"; Boss Instruments Item Number: 74-1448; Lot Number: 070412. 2) Instrumed Product Name: Cloward Spanner Gauge, Small 5 1/8"; Instrumed Product Number: 650-11864; Trade Name: CareFusion; CareFusion Product Name: Cloward Spanner Gauge, Small 5 1/8"; CareFusion Item Number: VM85-2559; Lot Number: 070412. 3) Instrumed Product Name: Cloward Spanner Gauge, Large 5 1/8"; Instrumed Product Number: 650-11869; Trade Name: Boss Instruments; Boss Instruments Product Name: Cloward Spanner Gauge, Large 5 1/8"; Boss Instruments Item Number: 74-1449; Lot Number: 070412.

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Product: Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries brand names.

1) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Schoitz Tonometer; Millennium Surgical Item Number: 3-5754; Lot Number: 030212. 2) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Schoitz Tonometer; Symmetry Surgical Item Number: 60-6031; Lot Numbers: 030212, 030413, 040113, 100312, 120113. 3) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Accutome; Accutome Product Name: Schoitz Tonometer; Accutome Item Number: AM0530; Lot Number: 030212, 120113. 4) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Boss Instruments; Boss Instruments Product Name: Schoitz Tonometer; Boss Instruments Item Number: 80-9010; Lot Number: 100312. 5) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Medline Industries; Medline Industries Product Name: Tonometer, Eye, Schiotz, w/ 3 Weights, Case; Medline Industries Item Number: MDG0781649; Lot Number: 030212, 040113, 100312, 120113.

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Product: Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name.

1) Instrumed Product Name: Schoitz Weights 7.5 grams; Instrumed Product Number: 720-55812; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Schoitz Weights 7.5 grams; Ambler Surgical Item Number: 5754B; Lot Number: 050411. 2) Instrumed Product Name: Schoitz Weights 15.0 grams; Instrumed Product Number: 720-55822; Trade Name: Ambler Surgical; Ambler Surgical Product Name: Schoitz Weights 15.0 grams; Ambler Surgical Item Number: 5754F; Lot Number: 050411.

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69471

Status: Resolved

Manufacturer: Instrumed International, Inc.

Manufactured In: United States

Units Affected: 28 products (26 tenaculum hooks; 26 endometrial suction curettes; 81 clamps; 11 trocars; 479 valvulotomes; 13 drills; 421 clamps; 74 trephines; 8 Hudson braces; 1 Hudson cerebellar extension; 9 perforating drills; 4 Cushing burrs; 16 Hudson burrs; 4 McKenzie perforator drills; 2 D'errico perforator drills; 3 McKenzie enlarging burrs; 5 Hudson cranial drill sets; 3 Galt trephines; 190 Gardner-Wells traction tongs; 67 replacement screw non-springloaded traction tongs; 49 lock nuts for titanium traction tongs; 22 titanium fixation screws, springloaded; 17 traction tong replacement screws, non-springloaded; 2 Gardner-Wells wrenches; 790 distractor screws; 5 Cloward Spanner gauges; 23 tonometers; 3 Schoitz weights)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

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Product: Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.

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Product: Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name.

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Product: Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.

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Product: McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.

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Product: Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.

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Product: Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69471

Status: Resolved

Manufacturer: Instrumed International, Inc.

Manufactured In: United States

Instrumed International, Inc.: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as &quot;Pre-Amendment&quot; devices.

Affected Products

Additional Information

Were You Affected by This Recall?

Instrumed International, Inc.: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as &quot;Pre-Amendment&quot; devices.

Affected Products

Additional Information

Were You Affected by This Recall?

Instrumed International, Inc.: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.

Instrumed International, Inc.: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.