Class 2 Device Recall AdVance"Male Sling System

• Date Initiated by Firm: October 15, 2014
• Date Posted: December 16, 2014
• Recall Status: Terminated on May 28, 2015
• Recall Number: Z-0806-2015
• Recall Event ID: 69796
• 510(K)Number: K053371
• Product Classification: Mesh, surgical, for stress urinary incontinence, male - Product Code OTM
• Product: AdVance"Male Sling System, REF 720088-01 &; AdVance" XP Male Sling System REF 720163-01; (not commercially available in the US) ; ; The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with attached connectors. One end of each helical needle passer is keyed to allow a secure attachment of the sling connectors. The sling mesh is constructed of polypropylene monofilament mesh that is precut to 1.2 centimeters arm width, 3.55 centimeters center width, and 35.5 centimeters length. Two absorbable tensioning sutures are threaded into the length of the mesh. Plastic sheaths are placed over each arm of the mesh to aide in ease of placement. The connectors are attached to the ends of the helical needle passers during the procedure. The mesh and suture portions of the sling are intended to remain in the body as a permanent implant and the mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.
• Code Information: REF 720088-01 Lot/Serial # 878849001 to 904928030 REF 720163-01 Lot/Serial # 767189001 to 905578100
• Recalling Firm/ Manufacturer: American Medical Systems, Inc.; 10700 Bren Rd W; Minnetonka MN 55343-9679
• For Additional Information Contact: AMS Customer Service; 800-328-3881 Ext. 6469
• Manufacturer Reason for Recall: During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model # 720088-01; AdVance" XP Male Sling System; Model # 720163-01; Monarc" C Subfacial Hammock; Model # 72404195; Monarc" + Subfacial Hammock; Model #
• FDA Determined Cause: Nonconforming Material/Component
• Action: Consignees were sent an AMS "Urgent Recall Notice" dated October 15, 2014. The letter was addressed to Physician, Health Care Professional, Nurse and Risk Manger. The letter described the problem and the product involved in the recall. Requested consignees to return all affected product and to complete and return the Acknowledgement Form. For questions, they can contact American Medical Systems Customer Service at 1-800-328-3881 (x6469). A second letter was available as optional communication to implanting physicians known by AMS to be regular users of the device. This physician letter was dated October 20, 2014.
• Quantity in Commerce: 10,085
• Distribution: Worldwide Distribution-US (nationwide) including DC and Puerto Rico and the countries of AUSTRIA, BELGIUM, CROATIA, CECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SLOVENIA, SERBIA, SOUTH AFRICA, SPAIN. SWEDEN, SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, COLUMBIA, COSTA RICA, HONG KONG, MALAYSIA, MARTINIQUE, NEW ZEALAND, PANAMA, PHILIPPINES, SINGAPORE, THAILAND, VENEZUELA, CANADA, AUSTRALIA.
• 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 = OTM and Original Applicant = AMERICAN MEDICAL SYSTEMS, INC.