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Ossur Americas, Inc. recalls The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Us
Recalled March 5, 2014 · FDA recall Z-1097-2014 · Ossur Americas
Hazard
OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down. · FDA Class II
Units
144 units
Sold at
US Nationwide distribution.
Description
OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
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.
Manufacturer(s)
Ossur Americas, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →