Device recall
Z-2755-2011: Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System…
FDA device recall · Class II · American Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2755-2011 |
|---|---|
| Recall event | 58850 |
| Product | 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… |
| Product code | FTL |
| Recalling firm | American Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 2012 |
| 510(k) numbers | K082677 |
| FEI number | 1000116179 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database