BEUDAMED
    FDA Recall Terminated

    Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.0 neck length on Co-Cr 12/14 tapers. Cat. No. 6418-26-03.

    Recall: Z-0460-03 · Initiated January 6, 2003

    Recall

    Recall Number
    Z-0460-03
    Event Number
    25257
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 6, 2003
    Posted
    January 23, 2003
    Terminated
    December 4, 2003
    Address
    345 E. Main St., Warsaw, IN, 46580

    Description

    Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.0 neck length on Co-Cr 12/14 tapers. Cat. No. 6418-26-03.

    Reason

    Compression test results are not in accordance with device approval submission

    Action

    Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.

    Distribution

    United States.