BEUDAMED
    FDA Recall Terminated

    Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. Used to drill or cut bone prior to implantation of screws

    Recall: Z-1430-2010 · Initiated September 3, 2009

    Recall

    Recall Number
    Z-1430-2010
    Event Number
    54541
    Firm
    Orthohelix Surgical Designs Inc
    FEI Number
    3000718467
    Product Code
    HTW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 3, 2009
    Posted
    April 22, 2010
    Terminated
    February 28, 2012
    Address
    1065 Medina Rd., Suite 500, Medina, OH, 44256

    Description

    Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. Used to drill or cut bone prior to implantation of screws

    Reason

    The epoxy is flaking off the drill bits and countersinks.

    Action

    On 9/3/2009 the firm sent letters to their customers requesting return of all recalled product in stock and for those products to be replaced with the ones listed in the letter. Questions should be directed to 330-869-0625.

    Distribution

    Nationwide Distribution -- CO, OH, PA, SD, TX & VA.

    Quantity

    74 pieces