BEUDAMED
    FDA Recall Terminated

    Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131

    Recall: Z-0074-2008 · Initiated August 24, 2007

    Recall

    Recall Number
    Z-0074-2008
    Event Number
    44787
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 24, 2007
    Posted
    December 13, 2007
    Terminated
    August 21, 2009
    Address
    1800 Pyramid Place, Memphis, TN, 38132-1719

    Description

    Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131

    Reason

    Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.

    Action

    Medtronic sent letters, titled URGENT DEVICE RECALL, on 08/24/2007, to the Risk Managers of the hospital consignees explaining the potential for these sets to disassemble, and requesting the discontinuation of the use of and quarantine of the product. The product will be retrieved by the firm and replaced.

    Distribution

    Worldwide Distribution - USA, The Netherlands, Australia, and Canada.

    Quantity

    20 units