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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 17, 2018 | Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 340 mm, Item Number: 814409340 | 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 280 mm, Item Number: 814509280 | 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 280 mm, Item Number: 814309280 | 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 440 mm, Item Number: 814409440 | 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 260 mm, Item Number: 814409260 | 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 400 mm, Item Number: 814413400 | 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 260 mm, Item Number: 814613260 | 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 460 mm, Item Number: 814511460 | 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 400 mm, Item Number: 814609400 | 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 300 mm, Item Number: 814511300 | 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 380 mm, Item Number: 814311380 | 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 340 mm, Item Number: 814311340 | 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¿ 13 mm x 180 mm, Item Number: 814513180 | 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 360 mm, Item Number: 814311360 | 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 320 mm, Item Number: 814511320 | 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 440 mm, Item Number: 814313440 | 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 440 mm, Item Number: 814511440 | 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 280 mm, Item Number: 814313280 | 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 400 mm, Item Number: 814311400 | 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 440 mm, Item Number: 814509440 | 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 340 mm, Item Number: 814611340 | 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 260 mm, Item Number: 814511260 | 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 440 mm, Item Number: 814311440 | 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 340 mm, Item Number: 814509340 | 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 420 mm, Item Number: 814609420 | 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 280 mm, Item Number: 814409280 | 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 320 mm, Item Number: 814613320 | 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 420 mm, Item Number: 814311420 | 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 280 mm, Item Number: 814413280 | 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 280 mm, Item Number: 814609280 | 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 300 mm, Item Number: 814413300 | 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 420 mm, Item Number: 814411420 | 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 260 mm, Item Number: 814609260 | 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 460 mm, Item Number: 814613460 | 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 420 mm, Item Number: 814511420 | 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 380 mm, Item Number: 814413380 | 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 320 mm, Item Number: 814509320 | 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 420 mm,Item Number: 814313420 | 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 380 mm, Item Number: 814409380 | 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 440 mm, Item Number: 814411440 | 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 400 mm, Item Number: 814511400 | 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 440 mm, Item Number: 814611440 | 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¿ 11 mm x 180 mm, Item Number: 814511180 | 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 320 mm, Item Number: 814611320 | 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 260 mm, Item Number: 814313260 | 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 320 mm, Item Number: 814311320 | 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 420 mm, Item Number: 814509420 | 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 440 mm, Item Number: 814513440 | 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 280 mm, Item Number: 814311280 | 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 460 mm, Item Number: 814313460 | 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.