Device product
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Z-0711-2017
Product summary
- Event
- Event 75715
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-0711-2017
Official wording
Reason: A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
Code information: 033T1022
Distribution pattern: US Nationwide Distribution in the states of CO, IL, IN, FL, CA, AZ
Derived failure modes
-
Labeling or packaging
mislabeled