Ossur Americas, Inc.
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 22, 23 and 24. The system is not intended for athletic use.
| Date | Feb 26, 2014 (initiated Oct 15, 2012) |
| Status | Terminated |
| Reason | OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down. |
| Root cause | Other |
| Action | Ossur Americas contacted all affected customers via phone on October 15, 2012 informing them that a software update for this product is required, along with the recommended instructions to return the product. A loaner prosthetic will be provided to the patient while the software update is being implemented. |
| Quantity | 144 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.