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Browse Device Recalls

875 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 875 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 875 FDA device recalls.

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DateProductReasonClassFirm
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Produc... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 P... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Pr... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 8, 2018 Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 ... There were complaints indicating that when the product was opened in surgery, the sterile packagi... Class II Zimmer Biomet, Inc.
Aug 3, 2018 Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol i... Expiration date incorrectly listed on the label Class II Zimmer Biomet, Inc.
Aug 2, 2018 Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, M... The implant only has one bolt in the sterile package but it should have had two. Class II Zimmer Biomet, Inc.
Aug 2, 2018 Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Mo... The implant only has one bolt in the sterile package but it should have had two. Class II Zimmer Biomet, Inc.
Jul 30, 2018 Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 P... The item is labeled as an 8.3mm, but it is actually a 12 mm. Class II Zimmer Biomet, Inc.
Jul 20, 2018 Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612 The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been ... Class II Zimmer Biomet, Inc.
Jul 20, 2018 Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629 The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been ... Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 400 mm, Item Number: 814411400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 320 mm, Item Number: 814409320 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 400 mm, Item Number: 814313400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 420 mm, Item Number: 814409420 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 300 mm, Item Number 814309300 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 360 mm, Item Number: 814309360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 300 mm, Item Number: 814509300 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 15 mm x 360 mm, Item Number: 814615360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 340 mm, Item Number: 814411340 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 460 mm, Item Number: 814409460 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 260 mm, Item Number: 814611260 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 380 mm, Item Number: 814309380 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 360 mm, Item Number: 814511360 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 340 mm, Item Number: 814511340 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 300 mm, Item Number: 814513300 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 440 mm, Item Number: 814515440 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 400 mm, Item Number: 814509400 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm, Item Number: 814509180 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 260 mm, Item Number: 814513260 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 420 mm, Item Number: 814513420 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 460 mm, Item Number: 814509460 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 380 mm, Item Number: 814611380 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 460 mm, Item Number: 814413460 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 320 mm, Item Number: 814515320 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 260 mm, Item Number: 814411260 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 420 mm, Item Number: 814309420 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, Inc.
Jul 17, 2018 Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 460 mm, Item Number: 814609460 The set screw is not able to advance or reverse from the original position in the nail. Class II Zimmer Biomet, 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.