Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

The Symbionic Leg is an integrated prosthetic leg for transfemoral Recalled by Ossur Americas, Inc. Due to OSSUR initiated this recall of the Symbionic Leg...

Date: February 12, 2012
Company: Ossur Americas, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ossur Americas, Inc. directly.

Affected Products

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.

Quantity: 17 units

Why Was This Recalled?

OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.

Where Was This Sold?

This product was distributed to 7 states: AL, GA, NJ, NY, OK, PA, DC

Affected (7 states)Not affected

About Ossur Americas, Inc.

Ossur Americas, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report