BEUDAMED
    FDA Recall Terminated

    Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Intended to determine proper anatomical orientation, selection, alignment and position of the acetabular and femoral components.

    Recall: Z-1915-2009 · Initiated September 11, 2007

    Recall

    Recall Number
    Z-1915-2009
    Event Number
    52676
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    IQO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 11, 2007
    Posted
    August 26, 2009
    Terminated
    October 15, 2009
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Intended to determine proper anatomical orientation, selection, alignment and position of the acetabular and femoral components.

    Reason

    The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking

    Action

    Stryker Orthopaedics issued an "Important Product Removal" letter dated September 11, 2007 via Federal Express informing consignees of the affected devices. The firm requested that users identify and return any affected product and account for product by returning a Product Accountability Form via fax. For further information, contact Stryker Orthopaedics at 1-201-831-5825.

    Distribution

    Nationwide Distribution

    Quantity

    615