Device recall
Z-2668-2011: AMS Acticon Neosphincter Pump, Product Number 72402287, Sterilization Method…
FDA device recall · Class II · American Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2668-2011 |
|---|---|
| Recall event | 58832 |
| Product | AMS Acticon Neosphincter Pump, Product Number 72402287, Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343. The Acticon Neosphincter is an implantable device used to treat severe fecal incontinence in males and females eighteen years and older who… |
| Product code | MIP |
| Recalling firm | American Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 6, 2012 |
| PMA numbers | P010020 |
| 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