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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

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DateProductReasonClassFirm
Feb 12, 2016 10mm X 12o Solitaire Ti Medium Spacer  Solitaire Anterior Spinal System, Mod... Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mi... Class II Biomet Spine, LLC
Sep 29, 2015 MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate... The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter scr... Class II Biomet Spine, LLC
Aug 5, 2015 Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cer... Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440. Class II Biomet Spine, LLC
Jul 22, 2015 Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Mod... Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft in... Class II Biomet Spine, LLC
Mar 12, 2015 Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxia... Multiaxial screws may not meet internal requirements related to fatigue strength. Compression te... Class II Biomet Spine, LLC
Mar 12, 2015 Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usa... Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/... Class II Biomet Spine, LLC
Mar 12, 2015 Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Us... Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/... Class II Biomet Spine, LLC
Aug 22, 2013 Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, M... The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when insertin... Class II Biomet Spine, LLC
Aug 22, 2013 Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 86... The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when i... Class II Biomet Spine, LLC
Aug 22, 2013 Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Ti... The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when insertin... Class II Biomet Spine, LLC
Nov 30, 2012 Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy... Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specific... Class II Biomet Spine, LLC
Feb 22, 2012 Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX,... Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due t... Class II Biomet Spine, LLC
Dec 19, 2011 Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is ... The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in pla... Class II Biomet Spine, LLC
Mar 9, 2011 LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization ... Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw... Class II Biomet Spine LLC.

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.