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Terminated

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, gynecological, and gastroenteriological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair. As configured, the Elevate Anterior device is used solely for prolapse repair

FDA Recall Z-2755-2011 · Posted 2011-07-07

Recalling FirmAmerican Medical Systems, Inc.
Recall StatusTerminated
Product CodeFTL
Date Initiated2011-05-09
Date Terminated2012-06-28
Product Quantity8563

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

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, SLOVAKIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, TAIWAN REPUBLIC OF CHINA, VENEZUELA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082677AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITEAmerican Medical Systems, Inc. · 2008-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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