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Browse Device Recalls

437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 437 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 437 FDA device recalls.

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DateProductReasonClassFirm
May 19, 2014 NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... Class II Zimmer, Inc.
Apr 1, 2014 TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous... The shell was missing the locking ring. Class II Zimmer, Inc.
Mar 19, 2014 DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment,... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 19, 2014 Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatmen... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 19, 2014 Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral st... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Mar 19, 2014 Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides com... During a transfer of products from a recently shutdown facility, the firm discovered raw material... Class II Zimmer, Inc.
Feb 25, 2014 Apollo" Knee System: APOLLO PATELLA SZ0 28MM R A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL P... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Gender Solutions" Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FL... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UN... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 ... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6M... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1 A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO ... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM ... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Feb 25, 2014 Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KN... A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the disc... Class II Zimmer, Inc.
Jan 10, 2014 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral St... This single manufacturing lot has the potential for the bond strength between the Trabecular Meta... Class II Zimmer, Inc.
Dec 19, 2013 Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement. After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, ... Class II Zimmer, Inc.
Dec 19, 2013 Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to addres... After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, ... Class II Zimmer, Inc.
Dec 10, 2013 Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The r... Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... Class II Zimmer, Inc.
Dec 10, 2013 CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/poly... Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... Class II Zimmer, Inc.
Dec 10, 2013 Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip... Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... Class II Zimmer, Inc.
Nov 19, 2013 NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 19, 2013 NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thic... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 19, 2013 NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm He... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 19, 2013 NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm He... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 19, 2013 NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thic... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 12, 2013 Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total a... As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial ... Class II Zimmer, Inc.
Nov 12, 2013 Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ... As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial ... Class II Zimmer, Inc.
Nov 12, 2013 Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total... As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial ... Class II Zimmer, Inc.
Nov 5, 2013 DIST LAT FEM LOCK PLT, LT Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 ITST THREADED GUIDE PIN Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 FEM COND BUTTRESS PLT, RT. Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 TIBIO FEM/FEM NAIL. Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 TIB NAIL Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 FEM COND BUTTRESS PLT, LT Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 DIST LAT FEM LOCK PLT, RT Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 NGK Stem Ext 24 x 245mm Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 4, 2013 Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 ... The patient label associated with the product may be incorrect in that the lot number on the pati... Class II Zimmer, Inc.
Oct 31, 2013 NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Ti... Two complaints were received in which it was reported that the stem would not lock into the tibia... Class II Zimmer, Inc.
Oct 17, 2013 Trabecular Metal" Reverse Shoulder System As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zi... Class II Zimmer, Inc.
Oct 11, 2013 PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENE... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 4... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LA... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.