Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

Recall date

January 5, 2026

Source

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

Recall number

Z-1233-2026

FDA classification

Class II

Brand / firm

Encore Medical, LP

Sold / distributed

US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA

Why it was recalled

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

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

What was recalled

EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705