Drug recall
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The…
FDA recall event 67249 · Class II · Ossur Americas, Inc.
Key facts
| Event ID | 67249 |
|---|---|
| Recall numbers | Z-0936-2014 |
| Recalling firm | Ossur Americas, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small batch of electronics. |
| Initiation date | Feb 12, 2012 |
| Report date | Feb 12, 2014 |
| Termination date | Feb 6, 2014 |
| City | Foothill Ranch |
| State | CA |
| Country | United States |
| FEI number | 2023821 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: