Reported Mar 5, 2014 · Terminated
The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage:…
Ossur Americas, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ossur Americas, Inc. · 19762 Pauling · Foothill Ranch, CA · 92610-2611
Is this the product you have?
- The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees
- Product UsageSYMBIONIC 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
- Lot codes and dates
- Symbionic Item NumbersSerial #s
SBL12002SBL12006SBL12012SBL12016SBL12102SBL12112SBL12202SBL12212SBL12902SBL12903SBL12912SBL12913
- affected
321245322095322276322894710119-710322
- Symbionic Item Numbers
- Amount recalled
- 144 units
Where it was sold
- Nationwide
Why it was recalled
OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
This product could cause temporary or reversible health problems — stop using it.
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