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Browse Device Recalls

437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 437 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 437 FDA device recalls.

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DateProductReasonClassFirm
Sep 4, 2012 NCB¿ screw ¿ 4.0 self-tapping Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Sep 4, 2012 Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw Zimmer Inc., is initiating a correction to the patient labels of products manufactured before Mar... Class II Zimmer, Inc.
Aug 31, 2012 Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usa... Zimmer Inc. is initiating a removal of the Multipolar¿ Bipolar Cup Liner 22 mm J.D. (item 00-5001... Class II Zimmer, Inc.
Aug 27, 2012 Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner ser... Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is p... Class II Zimmer, Inc.
Jul 18, 2012 00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle ... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 18, 2012 00-4309-029-00- Trabecular Metal Reverse Shoulder Liner 36mm, Nonsterile Per... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 18, 2012 Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per s... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 18, 2012 00-4309-029-01 - Trabecular Metal Reverse Shoulder Liner 36 mm 65¿¿ Neck Angl... Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to re... Class II Zimmer, Inc.
Jul 13, 2012 The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-ste... Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NC... Class II Zimmer, Inc.
Jun 5, 2012 PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrume... Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove ... Class II Zimmer, Inc.
Jun 5, 2012 Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle hand... Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been ... Class II Zimmer, Inc.
Jun 5, 2012 Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight h... Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been ... Class II Zimmer, Inc.
May 12, 2012 Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instr... Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Sto... Class II Zimmer, Inc.
Apr 1, 2011 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Fem... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 0078... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Fem... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 0078... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Fem... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femor... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Oct 10, 2010 . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys F... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Fem... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 Ver... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Fem... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 M... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 M... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 . 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys F... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 M... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 M... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 M... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Fem... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, 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.