BEUDAMED
    FDA Recall Terminated

    Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications.

    Recall: Z-0546-2010 · Initiated November 30, 2009

    Recall

    Recall Number
    Z-0546-2010
    Event Number
    53996
    Firm
    Medtronic Sofamor Danek Usa, Inc Dallas Distribution
    FEI Number
    1625507
    Product Code
    HBB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 30, 2009
    Posted
    December 17, 2009
    Terminated
    May 12, 2010
    Address
    4620 N Beach St, Fort Worth, TX, 76137-3219

    Description

    Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications.

    Reason

    Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.

    Action

    Medtronic issued an "Urgent: Medical Device Recall" letter dated November 30, 2009. Consignees were notified of the issued and asked to quarantine any affected product and return affected product to the firm for replacement. For further information, contact Medtronic Powered Surgical Solutions Customer Service at 1-800-433-7080 or 1-817-788-6400.

    Distribution

    Worldwide Distribution -- Including the United States (DC, TN, NC, KY, AL, FL, NJ, OH, MI, IN, NY, WA, CA, NV, NM, IA, MO, NE and UT), Great Britain, Brazil, Turkey, Singapore and the Netherlands.

    Quantity

    64