Device recall
Z-0209-2016: iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart…
FDA device recall · Class II · Otto Bock Healthcare GmbH
Key facts
| Recall number (Z-number) | Z-0209-2016 |
|---|---|
| Recall event | 72488 |
| Product | iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot. |
| Product code | ISH |
| Recalling firm | Otto Bock Healthcare GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2017 |
| FEI number | 3003117657 |
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