BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0449-2016 · Initiated December 2, 2015

    Recall

    Recall Number
    Z-0449-2016
    Event Number
    72729
    FEI Number
    1000132037
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    December 2, 2015
    Terminated
    September 16, 2016
    Address
    Zimmer Manufacturing B.V. Turpeaux Industrial Park Rd 1 km 123.4, Mercedita, PR, 00715

    Description

    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.

    Reason

    Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264

    Action

    An Urgent Medical Device Recall Letter, dated 12/2/15, was sent to the firm's consignees. All distributors will be notified via electronic mail. Hospital risk managers, surgeons, and distributors with product will be notified via courier.

    Distribution

    US Distribution and the country of Thailand.

    Quantity

    179