Device product
EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
Z-0102-2024
Product summary
- Event
- Event 93098
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 36
- Official record key
device-enforcement:Z-0102-2024
Official wording
Reason: Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
Code information: UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028
Distribution pattern: US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.
Derived failure modes
-
Unknown
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).