BEUDAMED
    FDA Recall Terminated

    Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.

    Recall: Z-0034-2012 · Initiated July 15, 2011

    Recall

    Recall Number
    Z-0034-2012
    Event Number
    59756
    Firm
    X Spine Systems Inc
    FEI Number
    3005031160
    Product Code
    FZS
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 15, 2011
    Posted
    October 11, 2011
    Terminated
    March 1, 2013
    Address
    452 Alexandersville Rd, Miamisburg, OH, 45342-3658

    Description

    Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.

    Reason

    The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque if the handles were turned at a very slow speed.

    Action

    X-spine Systems, Inc. sent an URGENT DEVICE RECALL letter dated September 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their stock immediately to determine if they have any affected product. If so, customers were instructed once the set screw is tightened onto the locking plate, and resistance is detected in the handle, it will take less than 2 seconds to hear the handle "click." The "click" indicates the torque limit was reached. If further resistance is felt after 2 seconds, the surgeon should release the handle from tension, and try again. If the product was distributed further, they should contact their accounts, and advise them of this recall. The firm will send replacement handles. For any questions call (937) 847-8400, ext 115.

    Distribution

    Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT.

    Quantity

    39 Torque Driver Handles