Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-
- Recall date
- 2026-07-15
- Brand
- Encore Medical, LP
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to packaging discrepancy with incorrect product size mixed up.
Product description
Due to packaging discrepancy with incorrect product size mixed up.
Affected products
Model/Catalog Number: 341-14-711 Lot Code: Lot: 145T1067 and 135T1060 GTIN: 00888912167086 Expiration Date: 12-06-2026 (145T1067) 12-07-2026 (135T1060)