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 initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics. |
| 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 adjust… |
| Quantity | 17 units |
| Distribution | US Distribution including the states of AL, DC, GA, NY, NJ, OK and PA. |
| Initiated | 2012-02-12 |
| Classified | 2014-02-06 |
| Terminated | 2014-02-06 |
| Recall number | Z-0936-2014 |
| 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-0936-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67249/
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