BEUDAMED
    FDA Recall Terminated

    Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111

    Recall: Z-0176-2007 · Initiated October 20, 2006

    Recall

    Recall Number
    Z-0176-2007
    Event Number
    36701
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    LYS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 20, 2006
    Posted
    November 14, 2006
    Terminated
    April 4, 2007
    Address
    1800 Pyramid Place, Memphis, TN, 38132-1719

    Description

    Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111

    Reason

    Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.

    Action

    The firm notified its consignees of the problem and the recall by letter delivered via overnight mail on 10/20/2006. The firm''s overseas distributors were also notified via electronic mail on 10/20/2006. The notices requested the discontinuation of use and stated that sales representatives would be retrieving the devices from them.

    Distribution

    Worldwide Distribution-USA and countries of The Netherlands, Hong Kong, and Japan.

    Quantity

    255 units