Device recall
Z-0936-2014: The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee…
FDA device recall · Class II · Ossur Americas, Inc.
Key facts
| Recall number (Z-number) | Z-0936-2014 |
|---|---|
| Recall event | 67249 |
| Product | The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected… |
| Product code | ISH |
| Recalling firm | Ossur Americas, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 6, 2014 |
| FEI number | 1000519909 |
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