American Medical Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0259-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product 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).

Product Classification:

Class II

Date Initiated: October 19, 2012

Date Posted: November 14, 2012

Recall Number: Z-0259-2013

Event ID: 63540

Reason for Recall:

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

Status: Terminated

Product Quantity: 4872

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated