Device product
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Z-0761-2025
Product summary
- Event
- Event 95882
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9
- Official record key
device-enforcement:Z-0761-2025
Official wording
Reason: Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
Code information: UDI-DI: 00888912167338. Lot: 076T1273A
Distribution pattern: US Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.
Derived failure modes
-
Unknown
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.