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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Feb 1, 2019 NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, ... Potentially comingled, resulting in the product in the box potentially not matching the product o... Class II Zimmer Trabecular Metal Technology, Inc.
Feb 1, 2019 NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, ... Potentially comingled, resulting in the product in the box potentially not matching the product o... Class II Zimmer Trabecular Metal Technology, Inc.
Jul 7, 2016 The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF devi... This field action is being initiated following the firm's discovery of a procedural error in the ... Class III Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 0058... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,2... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 007010050... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 005886... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Apr 15, 2016 TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 005886... Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal i... Class II Zimmer Trabecular Metal Technology, Inc.
Feb 4, 2015 NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Siz... One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed. Class II Zimmer Trabecular Metal Technology, Inc.
Dec 2, 2014 NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibi... During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial ... Class II Zimmer Trabecular Metal Technology, 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.