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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
May 30, 2019 Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V. The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ri... Class II Ortho Development Corporation
May 30, 2019 Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ri... Class II Ortho Development Corporation
Jul 11, 2014 Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA ... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TK... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Jul 11, 2014 Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila In... Class II Ortho Development Corporation
Apr 1, 2014 PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balan... A femoral component containing pegs was found in a box for the pegless version. Class II Ortho Development Corporation

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.