Zimmer, Inc.: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

Agency Publication Date: March 20, 2014

Affected Products

Product: Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT

Item Numbers 00541800000 00541800001 00541800002

Product: Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1

Item Number 00591101128 00591101137

Product: MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX TIB INS 6MM

Item Number 502001016 502004006 502004009 502004016 502010006

Product: Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CONG TIB INS SZ3/4 9MM UN CONG TIB INS SZ3/4 11MM U CONG TIB INS SZ3/4 13MM U CONG TIB INS SZ 5/6 9MM U CONG TIB INS SZ5/6 11MM U CONG TIB INS SZ5/6 13MM U

Item Number 611001009 611001011 611001013 611002009 611002011 611002013 611003009 611003011 611003013

Product: Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm

Item Number 613001007 613001009

Product: Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE

Item Number 620001100 620001101 620001102

Product: Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5

Item Number 620005819 620005909 620006916

Product: Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT SZA/11M ULTRA CONG INS RT SZA/13M ULTRA CONG INS RT SZA/19M ULTRA CONG INS LT SZB/13M ULTRA CONG INS LT SZB/16M ULTRA CONG INS RT SZB/19M ULTRA CONG INS RT SZB/22M NKII ROT PLTFM U/C INS, 9 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U

Item Number 625001609 625001613 625001619 625001709 625001711 625001713 625001719 625002613 625002616 625002719 625002722 630809510 630811410 630811510 630813410 630813510 630816210 630816410 630816510 630819010 630819110 630819210 630819310 630819410 630819510 635000009 635001009 635001011 635001111 635001116 635002009 635002011 635002109 635002111 635002113 635003009 635003011 635003013 635003016 635003109 635003113 635003116 635004009 635004011 635004016 635004111 635004113 635004119 635005013 635005019 635005111 635005116 635006109 670501916 670501919 670503819 670503911 670503916

Product: Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L

Item Number 672009100 672009101 672009103 672009200 672009203 672011101 672011103 672011200 672011201 672011203 672013100 672013101 672013103 672013200 672013203 672016101 672016103 672016200 672016203 672019100 672019101 672019200 672019201 672022101 672022103 672022200 672022201 672025100 672025200

Product: Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS TIB SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ

Item Number 672509100 672509101 672509200 672509203 672511100 672511103 672513101 672513103 672513201 672516103 672519103 672522201 672525103 672525203

Product: Apollo" Knee System: APOLLO PATELLA SZ0 28MM R

Item Number 680001000

Product: Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS SZ3/13MM APO

Item Number 681100019 681100022 681101009 681101011 681101019 681102013 681102019 681103009 681103013

Product: Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2/16M APOLLO PS TIB INS SZ2/22MM APOLL PS TIB INS SZ3/16MM APOLL PS TIB INS SZ3/19MM APOLL PS TIB INS SZ4/9MM APOLLO PS TIB INS SZ4/11MM APOLL PS TIB INS SZ4/13MM APOLL PS TIB INS SZ4/16MM APOLL PS TIB INS SZ4/19MM APOLL PS TIB INS SZ4/22MM APOLL PS TIB INS SZ5/9MM APOLLO PS TIB INS SZ5/19MM APOLL

Item Number Item Number 681600016 681600019 681600022 681601016 681602016 681602022 681603016 681603019 681604009 681604011 681604013 681604016 681604019 681604022 681605009 681605019

Product: Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB INSER SZ1-30MM AK CCK TIB INSER SZ2-11MM AK CCK TIB INSER SZ2-13MM AK CCK TIB INSER SZ2-16MM AK CCK TIB INSER SZ2-22MM AK CCK TIB INSER SZ2-30MM AK CCK TIB INSER SZ3-16MM AK CCK TIB INSER SZ3-22MM AK CCK TIB INSER SZ3-25MM AK CCK TIB INSER SZ4-13MM AK CCK TIB INSER SZ4-16MM AK CCK TIB INSER SZ5-11MM AK CCK TIB INSER

Item Number 682000016 682001011 682001016 682001022 682001030 682002011 682002013 682002016 682002022 682002030 682003016 682003022 682003025 682004013 682004016 682005011

Product: Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1 ALL POLY ULTRA TIB RT SZ1 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB RT SZ2 ALL POLY ULTRA TIB LT SZ3 ALL POLY ULTRA TIB RT SZ3 ALL POLY ULTRA TIB RT SZ5

Item Number 621800809 621801809 621801819 621801913 621801916 621810816 621810909 621820809 621820811 621820911 621830811 621830909 621850916

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 67503

Status: Resolved

Manufacturer: Zimmer, Inc.

Manufactured In: United States

Units Affected: 15 products (3638 units)

Were You Affected by This Recall?

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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

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