Device recall
Z-0209-2015: AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line…
FDA device recall · Class II · American Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0209-2015 |
|---|---|
| Recall event | 69536 |
| Product | AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place… |
| Product code | JCW |
| Recalling firm | American Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2015 |
| 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