Recall Z-0936-2014— Ossur Americas, Inc.

Class II FDA medical device recall by Ossur Americas, Inc., initiated 2012-02-12, terminated 2014-02-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics..

Recalling firm

Ossur Americas, Inc.

Classification

Class II

Status

Terminated

Initiated

2012-02-12

Terminated

2014-02-06

Firm location

Foothill Ranch, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.