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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Jan 7, 2022 NavitrackER Kit A: Knee, Model Number 20-8000-000-07, The product was released for distribution without passing sterilization results, which could pote... Class II Orthosoft, Inc. dba Zimmer CAS
Feb 20, 2017 SmartTools Knee System Orthopedic Stereotaxic Instrument There has been an increase in the number of complaints regarding bent or broken Drive Pins of the... Class II Orthosoft, Inc. dba Zimmer CAS
Oct 6, 2011 Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS ... Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Univers... Class II Orthosoft, Inc. dba Zimmer CAS
Jun 9, 2009 NDI P7 Position Sensor, Stereotaxic Instrument Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras)... Class II Orthosoft, Inc. dba Zimmer CAS
Oct 28, 2008 Navitrack System - OS Knee Universal, Stereotaxic instrument Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal... Class II Orthosoft, Inc. dba Zimmer CAS
Jun 20, 2008 Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Univers... Class III Orthosoft, Inc. dba Zimmer CAS
Jun 4, 2008 Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is u... Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk o... Class II Orthosoft, Inc. dba Zimmer CAS

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.