FDAFDA · Food and drugs·Recall number Z-1097-2014
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.
Published March 5, 2014 · Recall initiated: October 15, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Ossur Americas, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- Symbionic Item Numbers: SBL12002 SBL12006 SBL12012 SBL12016 SBL12102 SBL12112 SBL12202 SBL12212 SBL12902 SBL12903 SBL12912 SBL12913 Serial #s affected: 321245, 322095, 322276, 322894; 710119-710322
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.