EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 05, 2026 |
| Reported | February 11, 2026 |
| Recalling firm | Encore Medical, LP |
| Country / region | United States TX |
Hazard
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Affected products
- EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
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