BEUDAMED
    FDA Recall Terminated

    Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. Intended for use in cementless fixation fro use in total hip arthroplasty to relieve pain and restore function in the hip.

    Recall: Z-0909-2010 · Initiated February 17, 2006

    Recall

    Recall Number
    Z-0909-2010
    Event Number
    50150
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    February 17, 2006
    Posted
    March 2, 2010
    Terminated
    March 3, 2010
    Address
    325 Corporate Dr, Mahwah, NJ, 07430

    Description

    Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. Intended for use in cementless fixation fro use in total hip arthroplasty to relieve pain and restore function in the hip.

    Reason

    Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.

    Action

    Stryker Orthopaedics issued an "Important Market Withdrawal" notification dated February 17, 2007 via federal express. Consignees were informed of the affected product and asked to retrieve, reconcile and return product via Return Material Authorization to the firm. For further information, contact Stryker Orthopaedics Quality Assurance at 1-201-831-5825.

    Distribution

    Worldwide Distribution -- United States and Canada.

    Quantity

    594 units total - all products.