Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO, Manufactured by
FDA device recall Z-2755-2011 · posted 2011-07-07 · Terminated
Recall details
- Recalling firm
- American Medical Systems, Inc.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 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, ESTO
- Date initiated
- 2011-05-09
- Date posted
- 2011-07-07
- Date terminated
- 2012-06-28
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K082677) | American Medical Systems, Inc. | 2008-12-23 |