Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341
- Recall date
- 2026-03-04
- Brand
- Encore Medical, LP
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Knee and Humeral socket implants contain incorrect labeling.
Recommended action
What to do
14 implants
Product description
Knee and Humeral socket implants contain incorrect labeling.