BEUDAMED
    FDA Recall Terminated

    Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881060, 10mm, 5.5mm dia x 60mm, size: 10mm x 60mm, not for distribution in the U.S.A. or its territories, for spinal fixation.

    Recall: Z-1429-2008 · Initiated November 12, 2007

    Recall

    Recall Number
    Z-1429-2008
    Event Number
    46735
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    NQP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 12, 2007
    Posted
    September 11, 2008
    Terminated
    August 10, 2010
    Address
    1800 Pyramid Place, Memphis, TN, 38132-1719

    Description

    Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7881060, 10mm, 5.5mm dia x 60mm, size: 10mm x 60mm, not for distribution in the U.S.A. or its territories, for spinal fixation.

    Reason

    Breaks: Shear failure of the cable component of the system.

    Action

    Medtronic Sofamor Danek initiated its recall on 12/12/2007 by letter to all Risk Managers who received the product at their hospital. Letter were also mailed to surgeons who have implanted the product. Sales Representatives were notified via a conference call and letter to follow-up with thier respective surgeons who have implanted the product to verify that their surgeon received the communication of the recall and that they are aware that patient monitoring is recommended.

    Distribution

    Worldwide Distribution: USA, Canada, India, Venezuela, Netherlands, Chile, Brazil, and Australia.