The Symbionic Leg is an integrated prosthetic leg for transfemoral… — Class II medical device recall Z-0936-2014
Terminated recall by Ossur Americas, Inc., reported 2014-02-12, distributed in AL, DC, GA, NJ, NY, OK, PA. OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of ele
| Recall number | Z-0936-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ossur Americas, Inc., Foothill Ranch, CA, United States |
| Recall initiated | 2012-02-12 |
| Classified | 2014-02-06 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-02-06 |
| Distributed | AL, DC, GA, NJ, NY, OK, PA |
| Quantity | 17 units |
| Serial numbers | 321195, 321201, 710326, 710328, 710335, 710339, 710340, 710353, 710355, 710365, 710390, 710396, 710399, 710405, 710407, 710411, 710413 |
| Model numbers | SBL12012, SBL12903, SMBL2240, SMBL3260, SMBL3280, SMBL5250, SMBL5270, SMBL5280, SMBL7290 |
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 for recall
OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0936-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.