Home / Recalls / American Medical Systems, Inc. / Z-0259-2013

Z-0259-2013 Class II Terminated

Recalled by American Medical Systems, Inc. — Minnetonka, MN

FDA device recall Z-0259-2013 was initiated by American Medical Systems, Inc. on October 19, 2012 and is designated Class II. 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 r… The recall status is terminated (terminated April 11, 2013). Affected quantity: 4872.

Recall Details

Product Type: Devices
Report Date: November 14, 2012
Initiation Date: October 19, 2012
Termination Date: April 11, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4872

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).

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

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.

Code Information

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

Other recalls by American Medical Systems, Inc.

Z-0805-2015 Class II — AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Mona (October 15, 2014)
Z-0806-2015 Class II — AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 72 (October 15, 2014)
Z-0209-2015 Class II — AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessor (October 10, 2014)
Z-1280-2013 Class II — AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used (March 1, 2013)
Z-1279-2013 Class II — AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is use (March 1, 2013)