Recall Z-1097-2014— Ossur Americas, Inc.
Class II · Terminated
Class II FDA medical device recall by Ossur Americas, Inc., initiated 2012-10-15, terminated 2014-02-28. FDA's recall record names no specific 510(k) clearance for this event. 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 22, 23 and 24. The system is not intended for athletic use.. 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..
- Recalling firm
- Ossur Americas, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-15
- Terminated
- 2014-02-28
- Firm location
- Foothill Ranch, CA, United States
Product description
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.
Reason for recall
OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
Data sourced from openFDA. This site is unofficial and independent of the FDA.