Manufacturers

Ossur Americas, Inc.

2 devices in the database

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.
Device Recall SYMBIONIC LEG
  • Model / Serial
    Item Numbers: SBL12012, SMBL5250, SBL12903, SMBL5270, SMBL2240, SMBL5280, SMBL3260, SMBL7290, SMBL3280, Serial Numbers: 321195, 321201, 710326, 710328, 710335, 710339, 710340, 710353, 710355, 710365, 710390, 710396, 710399, 710405, 710407, 710411 and 710413
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.
  • Product Description
    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.