BEUDAMED
    FDA Recall Terminated

    ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516). Medtronic Sofamor Danek USA, Inc. This instrument is a precision device which incorporates a measuring function.

    Recall: Z-2985-2011 · Initiated July 6, 2011

    Recall

    Recall Number
    Z-2985-2011
    Event Number
    59221
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    XLH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 6, 2011
    Posted
    August 10, 2011
    Terminated
    April 26, 2013
    Address
    1800 Pyramid Place, Memphis, TN, 38132

    Description

    ATLANTIS(R) Anterior Cervical Plate System Screw Caddy; Self Drilling Fixed Screw Caddy (976-516). Medtronic Sofamor Danek USA, Inc. This instrument is a precision device which incorporates a measuring function.

    Reason

    Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws.

    Action

    Medtronic Sofamor Danek USA, Inc. sent "Voluntary Recall - Medtronic" letters on July, 2011 to all affected customers. The letter included; description of product and problem, and asked customers to stop using the product. Customers are asked to contact their Sales Representatives for replacement. For question on this recall call Medtronics Global Quality Department at (800) 876-3133.

    Distribution

    Worldwide Distribution: Nationwide distribution including the states of MN, OK, IL, AK, CA, PA, UT, LA, SC, NY, MI, GA, WI, KY, AL, MO, AZ, TN, TX, MA, NE, OH, FL, CO, MT, CT, VA, NC, NH, WA, WV, WY, IN, IA, KS, MT, ME, DE, DC, NJ, MD, MS, NV, HI, ID, ND, and AR; and the country of Uruguay.

    Quantity

    191 units