FDA DevicesClass II
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model...
Published: March 4, 2026Recall ID: Z-1459-2026Category: devicesCountry: US
Reason for Recall / Hazard
Knee and Humeral socket implants contain incorrect labeling.
Product Description & Identification
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Affected Products
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Additional Source Details
| Field | Value |
|---|---|
| City | Austin |
| State | TX |
| Event id | 98340 |
| Address 1 | 9800 Metric Blvd |
| Address 2 | N/A |
| Code info | Lot Code: Lot: 151T1055A GTIN: 00888912167147 |
| Postal code | 78758-5445 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 14 implants |
| Reason for recall | Knee and Humeral socket implants contain incorrect labeling. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260115 |
| Initial firm notification | Letter |
| Center classification date | 20260224 |
Overview
- Recalling FirmEncore Medical, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.