Z-1233-2026 Class II Ongoing

Recalled by Encore Medical, LP — Austin, TX

Recall Details

Product Type
Devices
Report Date
February 11, 2026
Initiation Date
January 5, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19

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.

Distribution Pattern

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