Drug recall
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
FDA recall event 95882 · Class II · Encore Medical, LP
Key facts
| Event ID | 95882 |
|---|---|
| Recall numbers | Z-0761-2025 |
| Recalling firm | Encore Medical, LP |
| Product type | Devices |
| Products | EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product. |
| Initiation date | Dec 10, 2024 |
| Report date | Jan 1, 2025 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 1000116912 |
At a glance
- 1–9 Products in this recall
- 10–99 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: