Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: ...
FDA Recall #Z-1459-2026 — Class II — January 15, 2026
Product Description
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Reason for Recall
Knee and Humeral socket implants contain incorrect labeling.
Recalling Firm
Encore Medical, LP — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
14 implants
Distribution
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
Code Information
Lot Code: Lot: 151T1055A GTIN: 00888912167147
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated