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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 28, 2017 Persona Partial Knee System Product Usage: The Persona Partial Knee Syste... Potential for the Persona Partial Knee Impactor Pad to fracture. Class II Zimmer Biomet, Inc.
Aug 25, 2017 AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804.... The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconfor... Class II Zimmer Biomet, Inc.
Aug 25, 2017 AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. ... The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconfor... Class II Zimmer Biomet, Inc.
Aug 25, 2017 G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arth... The affected products are labeled and etched as F-44 mm liners; however, the physical products co... Class II Zimmer Biomet, Inc.
Aug 22, 2017 Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant... Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors. Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 420MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 11MM X 380MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For ... There is a potential for intermittent cracks in the raw material batch used to produce the affect... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 F... There is a potential for intermittent cracks in the raw material batch used to produce the affect... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... Class II Zimmer Biomet, Inc.
Aug 7, 2017 Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM During the rework process for the April 17, 2017, field action, it was detected that the set scre... 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.