FDA Device recall Z-0936-2014
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees by Ossur Americas, citing OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0936-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-02-12 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ossur Americas |
| Distribution | AL, DC, GA, NJ, NY, OK, PA |
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.
Identifiers
| code_info | Item Numbers: SBL12012, SMBL5250, SBL12903, SMBL5270, SMBL2240, SMBL5280, SMBL3260, SMBL7290, SMBL3280, Serial Numbers…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Ossur Americas
- OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0936-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.