BEUDAMED
    FDA Recall Terminated

    Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 67MM, spinal implant component

    Recall: Z-0438-2010 · Initiated October 2, 2009

    Recall

    Recall Number
    Z-0438-2010
    Event Number
    53606
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 2, 2009
    Posted
    November 24, 2009
    Terminated
    January 23, 2013
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 67MM, spinal implant component

    Reason

    Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip.

    Action

    Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.

    Distribution

    Nationwide

    Quantity

    154