BEUDAMED
    FDA Recall Terminated

    Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Medtronic, Inc., Louisville, CO. Used in conjunction with the StealthStation navigation systems to assist in screw placement during spine surgery.

    Recall: Z-1042-2011 · Initiated December 15, 2010

    Recall

    Recall Number
    Z-1042-2011
    Event Number
    57549
    Firm
    Medtronic Navigation, Inc
    FEI Number
    1000517638
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 15, 2010
    Posted
    February 4, 2011
    Terminated
    May 4, 2011
    Address
    826 Coal Creek Circle, Louisville, CO, 80027-9710

    Description

    Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Medtronic, Inc., Louisville, CO. Used in conjunction with the StealthStation navigation systems to assist in screw placement during spine surgery.

    Reason

    Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery.

    Action

    Consignees were notified by a Product Correction Notification letter on 12/15/2010 and given the affected product and a description of the problem. The letter stated that a Medtronic representative would contact customers to visit their facility and replace the affected guide with one that has been correctly manufactured. Additional information is available at 800-595-9709.

    Distribution

    Worldwide Distribution -- USA, including states of GA, IL, IN, MN, MO, OH, OR, PA, and TX and countries of Denmark, Finland, Singapore, Spain, and UK.

    Quantity

    15 devices