Device recall
Z-1280-2013: AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to…
FDA device recall · Class II · American Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1280-2013 |
|---|---|
| Recall event | 64875 |
| Product | AMS 800 Urinary Control System. The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800 Urinary Control System is an implantable, fluid filled, solid silicone elastomer device… |
| Product code | EZY |
| Recalling firm | American Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 24, 2014 |
| PMA numbers | P000053 |
| FEI number | 1000116179 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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