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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 September 07, 2010
Date Posted December 27, 2010
Recall Status1 Terminated 3 on June 28, 2012
Recall Number Z-0808-2011
Recall Event ID 56846
510(K)Number K053371  
Product Classification Polymeric Surgical Mesh - Product Code FTL
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
Code Information 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.
Recalling Firm/
Manufacturer		 American Medical Systems, Inc.
10700 Bren Road West
Minnetonka MN 55343-9679
For Additional Information Contact Mark Heggestad
952-930-6495
Manufacturer 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.
FDA Determined
Cause 2		 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.
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.
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