BEUDAMED
    FDA Recall Terminated

    Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm O.D., use with 36 mm Head

    Recall: Z-0572-2007 · Initiated January 3, 2007

    Recall

    Recall Number
    Z-0572-2007
    Event Number
    37250
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    KWY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 3, 2007
    Posted
    March 7, 2007
    Terminated
    January 15, 2009
    Address
    5677 Airline Road PO Box 100, Arlington, TN, 38002-0100

    Description

    Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm O.D., use with 36 mm Head

    Reason

    Product specification failure which could result in improper locking of the cup onto the femoral head.

    Action

    The firm initiated the recall by telephoning its distributors on January 3, 2007 to request the return of the products. They followed with letters (mailed 1/15/07) to hospitals, implanting surgeons, and distributors requesting return of the product and informing them of the revision surgery that was a result of the problem.

    Distribution

    Nationwide and Japan

    Quantity

    14 units