The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral… — Class II medical device recall Z-1097-2014
Terminated recall by Ossur Americas, Inc., reported 2014-03-05, distributed nationwide. OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Sym
| Recall number | Z-1097-2014 |
|---|---|
| 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 | 2012-10-15 |
| Classified | 2014-02-26 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2014-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 144 units |
| Model numbers | SBL12002, SBL12006, SBL12012, SBL12016, SBL12102, SBL12112, SBL12202, SBL12212, SBL12902, SBL12903, SBL12912, SBL12913 |
Product
The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: 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 is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down.
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-1097-2014. 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.