EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
FDA Recall #Z-1233-2026 — Class II — January 5, 2026
Product Description
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Reason for Recall
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.
Recalling Firm
Encore Medical, LP — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
19
Distribution
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
Code Information
UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated