Devices

The SYMBIONIC LEG

Model / Serial
Symbionic Item Numbers: SBL12002 SBL12006 SBL12012 SBL12016 SBL12102 SBL12112 SBL12202 SBL12212 SBL12902 SBL12903 SBL12912 SBL12913 Serial #s affected: 321245, 322095, 322276, 322894; 710119-710322
Product Classification
Physical Medicine Devices
Distribution
US Nationwide distribution.
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.
Manufacturer
Ossur Americas, Inc.
1 Event
- Recall of The SYMBIONIC LEG

Manufacturer

Ossur Americas, Inc.

Manufacturer Address
Ossur Americas, Inc., 19762 Pauling, Foothill Ranch CA 92610-2611
Manufacturer Parent Company (2017)
Össur hf
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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