FDA DevicesClass II
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Published: February 11, 2026Recall ID: Z-1233-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Additional Source Details
| Field | Value |
|---|---|
| City | Austin |
| State | TX |
| Event id | 98177 |
| Address 1 | 9800 Metric Blvd |
| Address 2 | N/A |
| Code info | UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026 |
| Postal code | 78758-5445 |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 19 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260105 |
| Initial firm notification | N/A |
| Center classification date | 20260202 |
Overview
- Recalling FirmEncore Medical, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA