Recall Z-0259-2013 ยท FTL Mesh, Surgical, Polymeric
American Medical Systems, Inc.
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).
| Date | Nov 7, 2012 (initiated Oct 19, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 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, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053371 | AMS MALE TRANSOBTURATOR SLING SYSTEM American Medical Systems, Inc., Feb 3, 2006 |