Device product
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Z-1257-2022
Product summary
- Event
- Event 90230
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20
- Official record key
device-enforcement:Z-1257-2022
Official wording
Reason: A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
Code information: Lot number 078T1141
Distribution pattern: U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.
Derived failure modes
-
Labeling or packaging
mispackaged