Device recall
Z-1322-2015: The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower…
FDA device recall · Class II · Ossur H / F
Key facts
| Recall number (Z-number) | Z-1322-2015 |
|---|---|
| Recall event | 70693 |
| Product | The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain… |
| Product code | ISW |
| Recalling firm | Ossur H / F |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2015 |
| FEI number | 3003764610 |
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