BEUDAMED
    FDA Recall Terminated

    Zimmer Orthopaedic Surgical Products, Disposable Cuff, Single Port, Double Bladder Cuff, Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.

    Recall: Z-0565-05 · Initiated February 11, 2005

    Recall

    Recall Number
    Z-0565-05
    Event Number
    31206
    Firm
    Zimmer Orthopaedic Surgical Products
    FEI Number
    1035617
    Product Code
    KCY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 11, 2005
    Posted
    February 25, 2005
    Terminated
    April 7, 2006
    Address
    2021 Old Mountain Rd, Statesville, NC, 28625-1630

    Description

    Zimmer Orthopaedic Surgical Products, Disposable Cuff, Single Port, Double Bladder Cuff, Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.

    Reason

    The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.

    Action

    Consignees were notified by letter on 02/11/2005.

    Distribution

    Nationwide

    Quantity

    Total 430 cuffs