AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (I
FDA device recall Z-0259-2013 · posted 2012-11-07 · Terminated
Recall details
- Recalling firm
- American Medical Systems, Inc.
- 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
- Action taken
- 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. .
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 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, Croati
- Date initiated
- 2012-10-19
- Date posted
- 2012-11-07
- Date terminated
- 2013-04-11
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMS MALE TRANSOBTURATOR SLING SYSTEM (K053371) | American Medical Systems, Inc. | 2006-02-03 |