BEUDAMED
    FDA Enforcement Class II Terminated

    AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).

    Recall: Z-0259-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0259-2013
    Event ID
    63540
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    American Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2012
    Initiation Date
    October 19, 2012
    Classification Date
    November 7, 2012
    Termination Date
    April 11, 2013
    Address
    10700 Bren Rd W, N/A, Minnetonka, MN, 55343-9679, United States

    Description

    AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).

    Reason

    American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the

    Code Info

    Part # Lot/Serial Range 720088-01 722022001 to 796127002 720088-02 722024001 to 790266012 72404224 742528001 to 795689010

    Distribution

    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Croatia, India, Morocco, Mexico, Malaysia, Netherlands, New Zealand, Panama, Poland, Russian Federation, Solomon Islands, Singapore, Thailand, Turkey, Venezuela, South Africa, Chile, Colombia, Costa Rica, Slovenia, Argentina, China, and Taiwan.

    Quantity

    4872