BEUDAMED
    FDA Recall Terminated

    MaxTorque Cannulated Screw Model # MSD-010-55-060S

    Recall: Z-1250-2010 · Initiated April 7, 2009

    Recall

    Recall Number
    Z-1250-2010
    Event Number
    54540
    Firm
    Orthohelix Surgical Designs Inc
    FEI Number
    3000718467
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 7, 2009
    Posted
    April 6, 2010
    Terminated
    October 20, 2010
    Address
    1065 Medina Rd., Suite 500, Medina, OH, 44256

    Description

    MaxTorque Cannulated Screw Model # MSD-010-55-060S

    Reason

    A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw.

    Action

    On April 7, 2009 the firm sent letters to their customers with detailed instructions on how to correct the problem. Pictures were included for clarification. For questions please contact either Jim Bragg via phone at 330-869-9562 ext 211 or Kristin Wolff at ext 209.

    Distribution

    Product was delivered to: CA, CO, GA, NM, NY, OH, VA & WA.

    Quantity

    45 pieces