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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
Jul 23, 2014 VER2 HANDLE, PIN REWORK, RT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 23.5 Deg Rasp Handle Assy- LEFT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right) The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Right Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 VER2 DBL OFFSET RASP HANDLE, LT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Left Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 VI DBL OFFST W/ LRG STPL, LT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 23.5 Deg Rasp Handle Assy- RIGHT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Left Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Left Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Left Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Double Offset Rasp Handle, Right Hand Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 23, 2014 Vl DBL OFFST WI LRG STPL, RT Nonsterile The firm received complaints for failure of the handle to remain assembled to the rasp during use... Class II Zimmer, Inc.
Jul 22, 2014 4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zi... Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105L... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG ... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile... Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLA... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MI... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FN... Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... Class II Zimmer, Inc.
Jul 22, 2014 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 22, 2014 4.5 mm Malleolar Screw Sterile zimmer Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... Class II Zimmer, Inc.
Jul 17, 2014 Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Denta... Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8m... Class II Zimmer, Inc.
Jul 10, 2014 Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Nu... Zimmer received a trend of complaints indicating corrosion of product. Class II Zimmer, Inc.
Jul 10, 2014 Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Nu... Zimmer received a trend of complaints indicating corrosion of product. Class II Zimmer, Inc.
Jul 10, 2014 Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part N... Zimmer received a trend of complaints indicating corrosion of product. Class II Zimmer, Inc.
Jul 10, 2014 Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Nu... Zimmer received a trend of complaints indicating corrosion of product. Class II Zimmer, Inc.
Jul 1, 2014 Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 2... Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenest... Class II Zimmer, Inc.
Jul 1, 2014 PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non... The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the... Class II Zimmer, Inc.
Jul 1, 2014 PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non... The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the... Class II Zimmer, Inc.
Jun 25, 2014 Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006 Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant,... Class II Zimmer, Inc.
Jun 10, 2014 Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral C... A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an e... Class II Zimmer, Inc.
May 23, 2014 Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESI... Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Class II Zimmer, Inc.
May 23, 2014 Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, ... Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Class II Zimmer, Inc.
May 23, 2014 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESI... Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Class II Zimmer, Inc.
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.
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.
May 19, 2014 VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581 During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-... Class II Zimmer, Inc.
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.
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.
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.
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.
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.
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.

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.