BEUDAMED
    FDA Recall Terminated

    Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Medtronic Sofamor Danek, 1800 Pyramid Place Memphis, TN 38132, USA, Manufactured at: Bartlett, Tennessee, USA

    Recall: Z-0411-2007 · Initiated December 18, 2006

    Recall

    Recall Number
    Z-0411-2007
    Event Number
    37066
    Firm
    Medtronic Sofamor Danek Instrument Manufacturing
    FEI Number
    3004564008
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 18, 2006
    Posted
    February 8, 2007
    Terminated
    July 16, 2007
    Address
    2975 Brother Blvd, Bartlett, TN, 38133-3957

    Description

    Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Medtronic Sofamor Danek, 1800 Pyramid Place Memphis, TN 38132, USA, Manufactured at: Bartlett, Tennessee, USA

    Reason

    Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument during use.

    Action

    The firm sent out the recall letter via Federal Express to direct consignees on 12/18/2006. The letter explained the problem, requested discontinuation of use and stated that sales representatives would be coordinating the retrieval and replacement of the device.

    Distribution

    Worldwide, including USA, the Netherlands, Canada, Australia, and the Bahamas.

    Quantity

    58 units