BEUDAMED
    FDA Recall Terminated

    Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.

    Recall: Z-1784-2010 · Initiated March 23, 2010

    Recall

    Recall Number
    Z-1784-2010
    Event Number
    55256
    Firm
    Orthohelix Surgical Designs Inc
    FEI Number
    3000718467
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 23, 2010
    Posted
    June 10, 2010
    Terminated
    September 10, 2012
    Address
    1065 Medina Rd., Suite 500, Medina, OH, 44256

    Description

    Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.

    Reason

    On 3/9/10 it was discovered that the recalling firm packaged MFT-021-35-24 Screws from lot 0964092 as MFT-021-35-22 lot 0964081.

    Action

    OrthoHelix Surgical Designs, Inc. issued an "Important Field Correction Notice" dated March 23, 2010 via FedEx overnight. They instructed their customers to inventory their stock for affected product. All affected product will be replaced by the firm. For further information, contact OrthoHelix Surgical Designs, Inc. at 1-330-247-1444.

    Distribution

    Nationwide Distribution -- AZ, CA, CO, FL, GA, ID, IL, MD, NC, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA and WA.

    Quantity

    62 pieces