Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS recalled over labeling errors

Recall date

January 15, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707

Recall number

Z-1459-2026

FDA classification

Class II

Brand / firm

Encore Medical, LP

Sold / distributed

US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.

Why it was recalled

Knee and Humeral socket implants contain incorrect labeling.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707