BEUDAMED
    FDA Recall Terminated

    Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1

    Recall: Z-1019-04 · Initiated July 28, 2003

    Recall

    Recall Number
    Z-1019-04
    Event Number
    29142
    Firm
    American Medical Systems
    FEI Number
    1000116179
    Product Code
    FTL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 28, 2003
    Posted
    July 20, 2004
    Terminated
    June 22, 2004
    Address
    10700 Bren Rd, W Minnetonka, MN, 55343-9679

    Description

    Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1

    Reason

    Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles.

    Action

    The consignees were informed of the recall by telephone on 7/28/03 and told to return the product for replacement.

    Distribution

    The product was shipped to consignees in Connecticut, Indiana, MIchigan, North Carolina, Ohio, and Texas in the United States and to Belgium.

    Quantity

    62 units