BEUDAMED
    FDA Recall Terminated

    Omnifit HFX Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.

    Recall: Z-0896-2009 · Initiated November 13, 2008

    Recall

    Recall Number
    Z-0896-2009
    Event Number
    50485
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    November 13, 2008
    Posted
    January 26, 2009
    Terminated
    January 20, 2010
    Address
    325 Corporate Dr, Mahwah, NJ, 07430

    Description

    Omnifit HFX Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.

    Reason

    Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

    Action

    Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718.

    Distribution

    Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.

    Quantity

    322 total units - all types