FDA Enforcement
Class II
Ongoing
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Recall: Z-1233-2026
·
Reported February 11, 2026
Enforcement
- Recall Number
- Z-1233-2026
- Event ID
- 98177
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Encore Medical, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- February 11, 2026
- Initiation Date
- January 5, 2026
- Classification Date
- February 2, 2026
- Address
- 9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States
Description
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Reason
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.
Code Info
UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
Distribution
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
Quantity
19