Reported Nov 14, 2012 · Terminated
AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System…
American Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Medical Systems, Inc. · 10700 Bren Rd W · Minnetonka, MN · 55343-9679
Is this the product you have?
- 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).
- Lot codes and dates
- Part # Lot/Serial Range 720088-01 722022001 to 796127002 720088-02 722024001 to 790266012 72404224 742528001 to 795689010
- Amount recalled
- 4872
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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