Drug recall
The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product…
FDA recall event 67250 · Class II · Ossur Americas, Inc.
Key facts
| Event ID | 67250 |
|---|---|
| Recall numbers | Z-1097-2014 |
| Recalling firm | Ossur Americas, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Oct 15, 2012 |
| Report date | Mar 5, 2014 |
| Termination date | Feb 28, 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: