BEUDAMED
    FDA Recall Terminated

    Citation TMZF HA Hip Stem - RT. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.

    Recall: Z-1381-2009 · Initiated January 6, 2009

    Recall

    Recall Number
    Z-1381-2009
    Event Number
    50901
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 6, 2009
    Posted
    July 22, 2009
    Terminated
    June 25, 2012
    Address
    325 Corporate Dr, Mahwah, NJ, 07430

    Description

    Citation TMZF HA Hip Stem - RT. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.

    Reason

    Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.

    Action

    An "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.

    Distribution

    Nationwide Distribution.

    Quantity

    1,628 total stems, all varieties.