CLASS II Device recall · Reported 12 Feb 2014 · FDA Enforcement Report

The Symbionic Leg is an integrated prosthetic leg recalled

Ossur Americas is recalling The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee, distributed in 7 states. The recall was initiated on 12 Feb 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem 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

Quantity recalled17 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0936-2014
FDA event ID: 67249
Recalling firm: Ossur Americas, Foothill Ranch, CA
Classification: Class II
Status: Terminated
Recall initiated: 12 Feb 2012
FDA classified: 6 Feb 2014
Reported: 12 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

12 Feb 2012	Recall initiated by company
6 Feb 2014	Classified by FDA	+725 days
12 Feb 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.

Alabama District of Columbia Georgia New Jersey New York Oklahoma Pennsylvania

Questions about this recall

Is The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee recalled?

Yes. Ossur Americas recalled The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee on 12 Feb 2012. The recall is Class II and its status is Terminated. Recall number Z-0936-2014.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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