Device product
DJO EMPOWR KNEE Femoral Sizer
Z-1524-2021
Product summary
- Event
- Event 87332
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 units
- Official record key
device-enforcement:Z-1524-2021
Official wording
Reason: Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
Code information: Model Number: 800-05-034 Lot Number: 326336L02
Distribution pattern: U.S.: FL, IN, and MN O.U.S.: None
Derived failure modes
-
Manufacturing or process control
Incorrect assembly