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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Oct 16, 2023 Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality ... Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws ... Class II Zimmer Biomet Spine Inc.
Jul 30, 2018 Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (... The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vita... Class II Zimmer Biomet Spine Inc.
Jul 30, 2018 Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (no... The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vita... Class II Zimmer Biomet Spine Inc.
Jul 30, 2018 Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixat... The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vita... Class II Zimmer Biomet Spine Inc.
May 10, 2017 Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torq... Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality T... Class II Zimmer Biomet Spine 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.