BEUDAMED
    FDA Recall Terminated

    AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.

    Recall: Z-1235-2008 · Initiated January 28, 2008

    Recall

    Recall Number
    Z-1235-2008
    Event Number
    46833
    Firm
    American Medical Systems
    FEI Number
    1000116179
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 28, 2008
    Posted
    July 16, 2008
    Terminated
    October 13, 2010
    Address
    10700 Bren Rd, W Minnetonka, MN, 55343-9679

    Description

    AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System.

    Reason

    Missing part: The units in two lots of In-Fast Ultra Transvaginal Bladder Neck Support System may contain only one bone screw, but should contain two as indicated on the labeling. Two screws are required to complete the procedure. The missing screw will result in the inability to complete the procedure as expected if there are no additional screws readily available.

    Action

    All customers received phone calls on 1/28/08 explaining the error and associated risks and were followed up with detailed letters. The letter "AMS Important Product Recall" dated 1/28/08 described the product and problem. Customers were advised to return the enclosed "Recall Acknowledgement Form" to AMS along with any affected product that they have in inventory.

    Distribution

    Nationwide Distribution.