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    ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·November 28, 2012

    Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.

    FDA Recall
    Terminated ·Product code JWH·December 2, 2015

    NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 3, REF 00-5980-037-01, Sterile, Zimmer, Warsaw, IN. Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component and is indicated for cemented use only.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code JWH·January 26, 2010