Z-0936-2014Class II

The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The...

Name: Z-0936-2014 The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The...
Creator: Ossur Americas, Inc.
Published: 2012-02-12
License: https://open.fda.gov/license/

Ossur Americas / initiated 2012-02-12 / Terminated / root cause: manufacturing process

FDA source

Ossur Americas, Inc. began a recall of The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the... on 2012-02-12. FDA classified it as Class II and gives the reason as "OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0936-2014
Classification: Class II
Status: Terminated
Initiated: 2012-02-12
Posted: 2014-02-06
Terminated: 2014-02-06
Recalling firm: Ossur Americas
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.
Product code: ISH Component, External, Limb, Ankle/Foot
Reason for recall: OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: OSSUR contacted all affected customers via phone on February 12, 2013, informing them that a voluntary recall for this product has been implemented, along with the recommended instructions to return the product. A new replacement prosthetic will be provided to the customer. OSSUR has inspected and made appropriate modification to all inventory. ssur will also further strengthen the design and our manufacturing process to ensure an even more robust product. For further questions please call (949) 303-3239.
Quantity in commerce: 17 units
Distribution: US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0936-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0936-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-06

Product code ISH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)