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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
Jul 17, 2018 Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 380 mm, Item Number: 814513380 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 380 mm, Item Number: 814313380 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 260 mm, Item Number: 814509260 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 360 mm, Item Number: 814313360 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 340 mm, Item Number: 814413340 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 280 mm, Item Number: 814611280 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¿ 11 mm x 460 mm, Item Number: 814311460 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¿ 13 mm x 360 mm, Item Number: 814613360 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 380 mm, Item Number: 814511380 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 320 mm, Item Number: 814313320 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 320 mm, Item Number: 814609320 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 320 mm, Item Number: 814411320 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 380 mm, Item Number: 814411380 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 360 mm, Item Number: 814413360 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 420 mm, Item Number: 814611420 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¿ 13 mm x 380 mm, Item Number: 814613380 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 280 mm, Item Number: 814513280 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¿ 13 mm x 400 mm, Item Number: 814613400 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¿ 13 mm x 440 mm, Item Number: 814613440 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 360 mm, Item Number: 814609360 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 460 mm, Item Number: 814411460 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 340 mm, Item Number: 814513340 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 320 mm, Item Number: 814413320 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¿ 13 mm x 300 mm, Item Number: 814613300 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 340 mm, Item Number: 814313340 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 400 mm, Item Number: 814409400 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 320 mm, Item Number: 814309320 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 400 mm, Item Number: 814513400 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¿ 13 mm x 420 mm, Item Number: 814613420 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 300 mm, Item Number: 814313300 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¿ 13 mm x 340 mm, Item Number: 814613340 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¿ 11 mm x 300 mm, Item Number: 814311300 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 125¿ 11 mm x 180 mm, Item Number: 814311180 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 180 mm, Item Number: 814313180 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 420 mm, Item Number: 814413420 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 460 mm, Item Number: 814611460 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 260 mm, Item Number: 814413260 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 360 mm, Item Number: 814409360 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 125¿ 9 mm x 180 mm, Item Number: 814309180 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 360 mm, Item Number: 814515360 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¿ 13 mm x 280 mm, Item Number: 814613280 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 380 mm, Item Number: 814509380 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 300 mm, Item Number: 814409300 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 360 mm, Item Number: 814509360 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 400 mm, Item Number: 814611400 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 400 mm, Item Number: 814515400 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 360 mm, Item Number: 814611360 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 280 mm, Item Number: 814511280 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 360 mm, Item Number: 814411360 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 460 mm, Item Number: 814513460 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.