5 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
FDA Recall
Terminated
·Biomet, Inc.·Product code JDI·November 25, 2020
Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
FDA Recall
Terminated
·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007
OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·December 23, 2020
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·May 14, 2014
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017