Class II — Ossur Americas, Inc.
| Recalling firm | OSSUR Americas |
|---|---|
| Registered facility | View this company's 8 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal from the Symbionic Leg before it powers down. |
| 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. |
| Quantity | 144 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2012-10-15 |
| Classified | 2014-02-26 |
| Terminated | 2014-02-28 |
| Recall number | Z-1097-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ossur Americas, Inc. (Z-1097-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67250/
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