Medium RiskFDA Device

The Anspach Effort, Inc.: Supplied Directions for Use (DFU) did not contain a recommended service interval.

Agency Publication Date: May 4, 2017

Affected Products

Product: 14cm QD Angle Attachment Product Usage: Product attachment

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD14.

Product: AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AL-III-DISS-20

Product: AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0040 Part No. AL-III-DISS-30

Product: Foot control irrigation system Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AL-III-IRR

Product: Autolube-III Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III

Product: Autolube-III with 20ft hose Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-20

Product: AL-III-DISS Adapter Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-DISS

Product: Autolube-III with Foot Guard Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-FG

Product: Autolube-III with Irrigation Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-IRR

Product: Autolube-III with NK Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-NK

Product: 19cm Attachment, Black Max Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0062; Part No. BBLACK

Product: BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0040; Part No. BLACKMAX-N-LP

Product: IMRI AIR CONTROL Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0093; Part No. IMRI-FOOT-CTRL

Product: IMRI MOTOR Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0093; Part No. IMRI-MOTOR

Product: XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0040; Part No. xMAX.

Product: XMAX Motor, High Strength Hose Product Usage: Pneumatic system

All product shipped prior to 09/27/2016; DFU 18-0040; Part No. xMAX-H. Device Listing No. D015777.

Product: Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-FP-DIR/RR

Product: Electric Handpiece EM Hand Control Product Usage: Electric system

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-HC.

Product: Electronic Foot Control with Direction Switch Product Usage: Electric system

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-FP-DIR.

Product: Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-FP

Product: eMax2 Motor Assembly Product Usage: Electric system

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. eMax2.

Product: eMax2 Hybrid Hand Control Product Usage: Electric system

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. eMax2-HC.

Product: eMax2 PLUS Product Usage: Electric system

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. EMAX2PLUS.

Product: Foot Control, SC2100 Product Usage: Electric system

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. EPLUS-FP.

Product: Foot Control without Switches, SC2100 Product Usage: Electric system

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. EPLUS-FP-NS.

Product: Console, eMax2 Plus Product Usage: Electric system

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. SC2100.

Product: System Console, Single Port, with irrigation Product Usage: Electric system

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. SC2101.

Product: System Console, Single Port, no irrigation

All product shipped prior to 09/27/2016; DFU 18-0085; Part No. SC2102.

Product: 7.2cm Adjustable Drill Guide Product Usage: Electric system

All serial numbers shipped to customers; DFU 18-0048; Part No. ADG.

Product: 19CM ATTACHMENT, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-BLACK.

Product: 11.25CM ATTACHMENT, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-BLUE-S.

Product: LARGE CRANIOTOME, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-GOLD.

Product: STANDARD CRANIOTOME, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREEN.

Product: GREEN ROTATING CRANIOTOME, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREEN-R.

Product: ADJUSTABLE DRILL GUIDE, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREY-ADG.

Product: 16CM MIN INVASIVE ATTACH, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREY-MIA16.

Product: KEYLESS DRIVER, BLACK MAX

All serial numbers shipped to customers; DFU 18-0095; Part No. BM-DRIVER.

Product: 22CM MICRO REVISION ATTACH, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-L.

Product: 16.5CM MICRO REVISION ATTACH, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-M.

Product: 9.4CM MICRO REVISION ATTACH, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-S.

Product: CONTRA ANGLE ATTACHMENT, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-ORANGE-45.

Product: 90 DEG RIGHT ANGLE ATTACH, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-ORANGE-90.

Product: 11CM ANGLE ATTACHMENT, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD11.

Product: 10.5CM ANGLE ATTACHMENT, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD11-S.

Product: 14CM ANGLE ATTACHMENT, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD14.

Product: 13.5CM ANGLE ATTACHMENT, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD14-S.

Product: 8CM ANGLE ATTACHMENT, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD8.

Product: 7.5CM ANGLE ATTACHMENT, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD8-S.

Product: 26.65CM ATTACHMENT, BLACK MAX

All serial numbers shipped to customers; DFU 18-0062; Part No. B-RED.

Product: B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-SAGITTAL.

Product: 6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-SILVER.

Product: 12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQ-L.

Product: 5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQUOISE.

Product: PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQ-X.

Product: 8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-Violet.

Product: 6.8cm Controlled Depth Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CDA.

Product: Adult Craniotome Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. Crani-A.

Product: 6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-A-01.

Product: Rotating Adult Craniotome Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-A-R.

Product: Large Craniotome Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-L.

Product: Rotating Large Craniotome

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-L-R.

Product: Pediatric Craniotome

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-P.

Product: Compact Speed Reducer, 60:1

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0097; Part No. CSR60.

Product: Compact Speed Reducer, 60:1 Black Max

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0097; Part No. CSR60BM.

Product: Chuck Driver System

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. C-SYSTEM.

Product: Keyless Driver Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. DRIVER.

Product: IMRI CRANI-A ATTACHMENT Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-CRANI-A.

Product: IMRI SHORT ATTACHMENT Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-SHORT.

Product: IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-SHORT-HD.

Product: 11.0cm Long Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG.

Product: 10.5cm Long Attachment, Non-Tapered End Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-01.

Product: 12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-HD.

Product: 10.5cm Long Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-S.

Product: Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-10C.

Product: Bearing Sleeve, 10CM Straight Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-10S.

Product: Bearing Sleeve, 15CM Curved Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15C.

Product: Bearing Sleeve, 15CM Straight Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15S.

Product: Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15ST.

Product: Bearing Sleeve, 19CM Straight Taper Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-19ST.

Product: Minimal Access Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-D21.

Product: Minimal Access Attachment, BLACK MAX Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-D20BM.

Product: Minimal Access Straight Driver Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-Driver.

Product: 8.0cm Medium Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MEDIUM.

Product: 8.0CM Heavy Duty Medium Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MEDIUM-HD.

Product: 16cm Minimally Invasive Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MIA16.

Product: Sagittal Saw Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MM-SAGITTAL.

Product: Otologic Curved Micro Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0100; Part No. OCM.

Product: 45 degree Contra Angle Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0030; Part No. ORANGE-45.

Product: 90 degree Contra Angle Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0030; Part No. ORANGE-90.

Product: Oscillating MICRO-SAW Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. O-SAW.

Product: 11cm QD Angle Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD11.

Product: 10.5cm QD Angle Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD11-S.

Product: 14cm QD Angle Attachment Product Usage: Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD14.

Product: 14cm QD Angle Attachment

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD14-S.

Product: 8cm QD Angle Attachment

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD8.

Product: 7.5cm QD Angle Attachment

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD8-S.

Product: Reciprocating MICRO SAW

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. R-SAW.

Product: SMALL ATTACHMENT, JACOBS CHUCK

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. SA-JACOBS.

Product: SMALL ATTACHMENT, J-LATCH

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. SA-JLATCH.

Product: 5.0cm Short Attachment

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. SHORT.

Product: 5.0cm Heavy Duty Short Attachment

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. SHORT-HD.

Product: Sagittal MICRO-SAW

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. S-SAW.

Product: 20.2cm Heavy Duty Long Heavy Short Attachment

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. XL-HD.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76059

Status: Resolved

Manufacturer: The Anspach Effort, Inc.

Manufactured In: United States

Units Affected: 101 products (19; 17; 1; 239; 16; 5; 17; 51; 1; 41; 25; 3; 3; 554; 22; 207; 32; 209; 821; 158; 293; 3,434; 320; 22; 439; 462; 239; 198; 41; 216; 31; 148; 8; 6; 4; 5; 25; 17; 11; 2; 10; 45; 13; 17; 1; 1; 3; 16; 5; 297; 297; 49; 3; 80; 4; 2878; 130; 49; 930; 8; 679; 714; 128; 8; 121; 10; 14; 5; 3504; 4; 9829; 247; 182; 112; 224; 568; 121; 58; 618; 22; 98; 1802; 1202; 177; 22; 119; 5; 16; 455; 203; 238; 91; 415; 375; 65; 50; 16; 5757; 2339; 62; 206)

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.