Z-1459-2026 Class II Ongoing

Recalled by Encore Medical, LP — Austin, TX

Recall Details

Product Type
Devices
Report Date
March 4, 2026
Initiation Date
January 15, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14 implants

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.

Distribution Pattern

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