FDA DeviceClass IINotable

FDA Recall: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341

Name: FDA Recall: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341
Brand: Encore Medical, LP

Date: 2026-03-04

Brand: Encore Medical, LP

Category: Medical Device

FDA Class: Class II

Description

Knee and Humeral socket implants contain incorrect labeling.

Hazard

Knee and Humeral socket implants contain incorrect labeling.

Remedy

14 implants

View original recall →