BEUDAMED
    FDA Recall Terminated

    The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of degenerative Spondylolisthesis.

    Recall: Z-1554-05 · Initiated May 16, 2005

    Recall

    Recall Number
    Z-1554-05
    Event Number
    32212
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 16, 2005
    Posted
    September 21, 2005
    Terminated
    December 2, 2005
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of degenerative Spondylolisthesis.

    Reason

    The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence.

    Action

    The notification letters and product accountability forms were sent to their branches/agencies and the one hospital via Fedex on 5/16/2005 with return receipt.

    Distribution

    Stryker distributes their product though branches/agencies and occassionally directly to hospitals. These branches/agencies are located nationwide and will deliver the device to the medical facility. There are 31 branches and 1 hospital involved.

    Quantity

    107