Z-1097-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 5, 2014
- Initiation Date
- October 15, 2012
- Termination Date
- February 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144 units
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.
Reason for Recall
OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
Distribution Pattern
US Nationwide distribution.
Code Information
Symbionic Item Numbers: SBL12002 SBL12006 SBL12012 SBL12016 SBL12102 SBL12112 SBL12202 SBL12212 SBL12902 SBL12903 SBL12912 SBL12913 Serial #s affected: 321245, 322095, 322276, 322894; 710119-710322