Device recall
Z-0785-2007: AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18…
FDA device recall · Class II · American Medical Systems
Key facts
| Recall number (Z-number) | Z-0785-2007 |
|---|---|
| Recall event | 37437 |
| Product | AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Tactile Pump, 2 Cylinders. |
| Product code | JCW |
| Recalling firm | American Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2008 |
| FEI number | 1000116179 |
At a glance
- None 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