FDA-Device2014-03-05Class II
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.
Ossur Americas, Inc.
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.
Sold states
US Nationwide distribution.
Affected count
144 units
Manufactured in
19762 Pauling, Foothill Ranch, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1097-2014Don't want to check this manually?
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