Z-1233-2026 Class II Ongoing
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