• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 63540
Product Type Devices
Status Ongoing
Recalling Firm American Medical Systems, Inc.
City Minnetonka
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-19
Initial Firm Notification of
Consignee or Public
Letter
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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). Part # Lot/Serial Range 720088-01 722022001 to 796127002 720088-02 722024001 to 790266012 72404224 742528001 to 795689010 Class II 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 expiration of the labeled shelf life. At this time AMS cannot confirm that there is no potential for premature degradation of the bioabsorbable tensioning sutures on the product included in this recall. 4872 Z-0259-2013
-
-