BEUDAMED
    FDA Recall Terminated

    Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at: Warsaw, Indiana USA, Rx only

    Recall: Z-0654-2007 · Initiated February 2, 2007

    Recall

    Recall Number
    Z-0654-2007
    Event Number
    37376
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 2, 2007
    Posted
    March 27, 2007
    Terminated
    August 11, 2007
    Address
    1800 Pyramid Place, Memphis, TN, 38132-1719

    Description

    Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at: Warsaw, Indiana USA, Rx only

    Reason

    Bone screws may pull though the plate.

    Action

    Medtronic Global Quality initiated the recall via letter on 02/02/2007. Sub-recalls will be managed by Medtronic EMEA quality (Europe, Middle East, and Africa) in the affected geographies. Distributors and surgical facilities will be contacted as well as regulatory bodies in each country.

    Distribution

    France, Germany, Italy, UK, and Tunisia. No US distribution.

    Quantity

    293 units