BEUDAMED
    FDA Recall Terminated

    Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    Recall: Z-0792-2010 · Initiated January 18, 2010

    Recall

    Recall Number
    Z-0792-2010
    Event Number
    54274
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    LHX
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    January 18, 2010
    Posted
    February 16, 2010
    Terminated
    September 6, 2012
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    Reason

    Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which may compromise the sterility of the product.

    Action

    Stryker Spine issued an "Urgent Product Recall" notification dated January 15, 2010 via Federal Express to all consignees. The letter informed users of the issue and potential hazards of the affected product. For further information, contact your local Stryker Spine Sales Representative or call 201-760-8206.

    Distribution

    Nationwide distribution.

    Quantity

    2717 total, all sizes.