Recall Z-0806-2015 ยท OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
American Medical Systems, Inc.
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 m
| Date | Dec 16, 2014 (initiated Oct 15, 2014) |
| Status | Terminated |
| Reason | 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 # |
| Root 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 |
| Quantity | 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. 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 |