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U.S. Department of Health and Human Services

Class 2 Device Recall AdVance Male Sling System

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  Class 2 Device Recall AdVance Male Sling System see related information
Date Initiated by Firm October 19, 2012
Date Posting Updated November 07, 2012
Recall Status1 Terminated 3 on April 11, 2013
Recall Number Z-0259-2013
Recall Event ID 63540
510(K)Number K053371  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product 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).
Code Information Part # Lot/Serial Range

720088-01 722022001 to 796127002, 720088-02 722024001 to 790266012, 72404224 742528001 to 795689010

Recalling Firm/
American Medical Systems, Inc.
10700 Bren Rd W
Minnetonka MN 55343-9679
For Additional Information Contact
Manufacturer 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
FDA Determined
Cause 2
Device Design
Action American Medical Systems sent an "URGENT MEDICAL DEVICE RECALL" dated October 18, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to return any existing stock of the recall product and to complete and return the Product Recall Acknowledgment Form. Contact AMS Customer Service at 1-800-328-3881 for additional information or questions. .
Quantity in Commerce 4872
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = AMERICAN MEDICAL SYSTEMS, INC.