BEUDAMED
    FDA Enforcement Class II 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 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0449-2016
    Event ID
    72729
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Manufacturing B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2015
    Initiation Date
    December 2, 2015
    Classification Date
    December 18, 2015
    Termination Date
    September 16, 2016
    Address
    Turpeaux Industrial Park Rd 1 km 123.4, N/A, Mercedita, PR, 00715, United States

    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

    Code Info

    lot #62460264

    Distribution

    US Distribution and the country of Thailand.

    Quantity

    179