Z-0808-2011

Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL...

Name: Z-0808-2011 Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL...
Creator: American Medical Systems, Inc.
Published: 2010-09-07
License: https://open.fda.gov/license/

American Medical Systems, Inc. / initiated 2010-09-07 / Terminated / root cause: packaging

FDA source

American Medical Systems, Inc. began a recall of Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL... on 2010-09-07. The reason FDA records is "American Medical Systems (AMS) is recalling all lots of the AdVance male Sling System with an expiration date between July 2012 and August 2013. Internal testing has indicated the potential for degradation of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0808-2011
Status: Terminated
Initiated: 2010-09-07
Posted: 2010-12-27
Terminated: 2012-06-28
Recalling firm: American Medical Systems, Inc.
Product: Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL. Sterilization Method ETO, American Medical systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: American Medical Systems (AMS) is recalling all lots of the AdVance male Sling System with an expiration date between July 2012 and August 2013. Internal testing has indicated the potential for degradation of the bioabsorbable tensioning sutures when the product is stored for longer than 15 months after the date of manufacture.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Consignees were sent an AMS "Urgent Product Recall" letter dated September 7, 2010. The letter described the problem and the product involved. They requested consignees to return any existing stock product and to return the Product Recall Acknowledgement form enclosed. Customers may request a credit or a full refund or also, arrange for replenishment of AdVance product. Questions regarding the recall should be directed towards AMS Customer Service at 1-800-328-3881.
Quantity in commerce: 7,069
Distribution: Worldwide Distribution -- All states in the Continental USA including DC and Puerto Rico and countries of ARGENTINA, AUSTRIA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, COSTA RICA, GERMANY, ESTONIA, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GREECE, HONG KONG, CROATIA, IRELAND, ISRAEL, INDIA, ITALY, REPUBLIC OF KOREA, LEBANON, MOROCCO, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, PANAMA, POLAND, PORTUGAL, RUSSIAN FEDERATION SAUDI ARABIA, SWEDEN SINGAPORE, SLOVENIA, THAILAND, TURKEY, TAIWAN, VENEZUELA, and SOUTH AFRICA.
Product codes and lots: The affected Lot Serial Number Range is 615445001 - 669783001 (The Lot Serial Number is comprised of nine digits. The first 6 digists represent the parent lot number, followed by the last 3 digits which represents the serial number). All lots of the AdVance male Sling System with an expiration date between July 2012 and August 2013.

Product code FTL

K053371Class IIAms Male Transobturator Sling SystemAmerican Medical Systems, Inc. / cleared 2006-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)