Reported Feb 12, 2014 · Terminated
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is…
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. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). 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.
- Lot codes and dates
- Item Numbers
SBL12012SMBL5250SBL12903SMBL5270SMBL2240SMBL5280SMBL3260SMBL7290SMBL3280
- Serial Numbers
321195321201710326710328710335710339710340710353710355710365710390710396710399710405710407710411 and 710413
- Item Numbers
- Amount recalled
- 17 units
Where it was sold
Why it was recalled
OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
This product could cause temporary or reversible health problems — stop using it.
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