Device recall
Z-1097-2014: 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-1097-2014 |
|---|---|
| Recall event | 67250 |
| Product | The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less than 100kg for foot categories… |
| Recalling firm | Ossur Americas, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2014 |
| FEI number | 1000519909 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
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