BEUDAMED
    FDA Recall Terminated

    Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, SIZE 7 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA

    Recall: Z-0141-2008 · Initiated September 4, 2007

    Recall

    Recall Number
    Z-0141-2008
    Event Number
    44953
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    MJO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 4, 2007
    Posted
    December 19, 2007
    Terminated
    November 3, 2008
    Address
    1800 Pyramid Place, Memphis, TN, 38132-1719

    Description

    Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, SIZE 7 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA

    Reason

    Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.

    Action

    The firm notified their consignees of the problem and the recall by Urgent Medical Device Recall letter, telephone calls and electronic mail on 09/04/2007. Instructions include requests to immediately quarantine the product and hold for recalling firm collection.

    Distribution

    Nationwide

    Quantity

    196 units