BEUDAMED
    FDA Recall Terminated

    Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137.

    Recall: Z-1067-05 · Initiated June 29, 2005

    Recall

    Recall Number
    Z-1067-05
    Event Number
    32560
    Firm
    Medtronic Powered Surgical Solutions
    FEI Number
    1625507
    Product Code
    HBB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 29, 2005
    Posted
    August 3, 2005
    Terminated
    September 24, 2007
    Address
    4620 N Beach St, Fort Worth, TX, 76137-3219

    Description

    Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137.

    Reason

    Complaints of finger control component breaking off and falling into open surgical wound.

    Action

    The firm initiated the recall via letter on July 1, 2005.

    Distribution

    Nationwide. The device was distributed to hospitals and medical facilities in AL, AR, CA, CT, DC, DE, FL, HI, IA, IL, IN, ME, MN, MT, NC, NE, NJ, NM, NY, OH, PA, SC, TN, TX, and VA. Devices were also distributed to the following foreign countries: Japan, Mexico, Netherlands, Canada, and Venezuela.

    Quantity

    191 motors