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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Date	Product	Reason	Class	Firm
Aug 30, 2013	Metasul¿ Head. Intended for use either with or without bone cement in tota...	The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s...	Class II	Zimmer, Inc.
Aug 30, 2013	NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the Unit...	The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s...	Class II	Zimmer, Inc.
Aug 30, 2013	CoCr Head (Not distributed in the United States) Used in total hip replace...	The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s...	Class II	Zimmer, Inc.
Aug 30, 2013	Natural-Knee¿ Flex Femoral Component. Provides increased flexion capability.	The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s...	Class II	Zimmer, Inc.
Aug 28, 2013	VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Herit...	Based on a review of historic packaging validations, it was determined that a subset of product p...	Class II	Zimmer, Inc.
Aug 28, 2013	Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates Th...	Zimmer recently conducted a review of historic packaging validations completed. Based on this re...	Class II	Zimmer, Inc.
Aug 26, 2013	Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, ...	Possibility of the weld to the quick-connect breaking when force is applied to the handle for pe...	Class II	Zimmer, Inc.
Aug 1, 2013	00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, ...	Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distracto...	Class II	Zimmer, Inc.
Jul 30, 2013	ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLAT...	Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, ...	Class II	Zimmer, Inc.
Jul 16, 2013	Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Ste...	Zimmer recently conducted a review of historic packaging validations completed. Based on this re...	Class II	Zimmer, Inc.
Jun 28, 2013	REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, ...	There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to frac...	Class II	Zimmer, Inc.
Jun 28, 2013	REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, ...	There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to frac...	Class II	Zimmer, Inc.
Jun 19, 2013	VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 m...	Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t...	Class II	Zimmer, Inc.
Jun 19, 2013	VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor...	Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t...	Class II	Zimmer, Inc.
Jun 19, 2013	Free Lock Femoral Hip Fixation System Compression Tube/Plate, different lengt...	Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t...	Class II	Zimmer, Inc.
Jun 19, 2013	Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths...	Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t...	Class II	Zimmer, Inc.
Jun 19, 2013	VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and shor...	Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak t...	Class II	Zimmer, Inc.
Jun 11, 2013	Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12m...	The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4...	Class II	Zimmer, Inc.
Jun 10, 2013	Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provi...	Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface...	Class II	Zimmer, Inc.
Jun 10, 2013	Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provi...	Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface...	Class II	Zimmer, Inc.
Jun 10, 2013	Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Prov...	Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface...	Class II	Zimmer, Inc.
Jun 10, 2013	Persona (TM) The Personalized Knee System Tibial Articular Surface Provisio...	Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface...	Class II	Zimmer, Inc.
Jun 10, 2013	Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provi...	Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface...	Class II	Zimmer, Inc.
Jun 10, 2013	Persona (TM) The Personalized Knee System Tibial Articular Surface Provisio...	Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface...	Class II	Zimmer, Inc.
Jun 7, 2013	90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; ...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597001131 Femur CR PRC SURF HDN FEM CO-N...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 ...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; ...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; ...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 0059500...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-F...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 ...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile; 005...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; ...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur ...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 F...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 0059870...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 ...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; ...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Fem...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 9...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 005971011...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	Class II	Zimmer, Inc.
Jun 7, 2013	00597001101 Femur CR PRECOAT FEM COMP SIZE...	Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in ...	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.