Recall Z-2755-2011 ยท FTL Mesh, Surgical, Polymeric
American Medical Systems, Inc.
Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO, Manufactured by:American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA Product Usage: The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecologica
| Date | Jul 7, 2011 (initiated May 9, 2011) |
| Status | Terminated |
| Reason | This is an important notification regarding the Elevate Anterior and Apical Prolapse Repair Systems, Part Number 720093-01, manufactured between August 3, 2010 and January 17, 2011. We have recently received complaints stating that the eyelets were missing from the center graft of some units within the scope of this issue. The complaint rate to-date for the affected product is 0.045%, however th |
| Root cause | Process control |
| Action | American Medical Systems (AMS) sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 9, 2011 to all customers who received the recalled product. The letter identified the product, problem, and emphasize that the recalled product should not be implanted. The customers were instructed to examine their inventory for the recalled product and call AMS Customer Service at 1-800-328-3881 (select option 1) for an exchange of the product. For assistance in evaluating inventory the customers are instructed to contact their local AMS sales representative. |
| Quantity | 8563 |
| Distribution | Worldwide Distribution -- USA (nationwide) including DC and Puerto Rico and countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, FRANCE, GERMANY, PORTUGAL SPAIN, UNITED KINGDOM, ARGENTINA, COLOMBIA, ESTONIA, FINLAND, GREECE, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NEW ZEALAND, SAUDI ARABIA, SLOVA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082677 | AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE American Medical Systems, Inc., Dec 23, 2008 |