BEUDAMED
    FDA Recall Terminated

    Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland

    Recall: Z-0795-2007 · Initiated April 20, 2007

    Recall

    Recall Number
    Z-0795-2007
    Event Number
    37805
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    FTM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 20, 2007
    Posted
    May 10, 2007
    Terminated
    March 4, 2008
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland

    Reason

    The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01)

    Action

    Recall notifications were sent by 2nd day air UPS delivery on April 20, 2007 to all hospitals Director of Surgery, OR Managers and Materials Managers.

    Distribution

    Nationwide

    Quantity

    160 units to US