Device recall
Z-2438-2015: Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer…
FDA device recall · Class II · Otto Bock Healthcare Product
Key facts
| Recall number (Z-number) | Z-2438-2015 |
|---|---|
| Recall event | 71950 |
| Product | Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings. |
| Product code | ISW |
| Recalling firm | Otto Bock Healthcare Product |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 28, 2015 |
| FEI number | 3005190268 |
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