Device product
Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
Z-0165-2016
Product summary
- Event
- Event 72216
- Status
- Terminated
- Classification
- Class II
- Quantity
- 209 units
- Official record key
device-enforcement:Z-0165-2016
Official wording
Reason: The labeling is missing the size/diameter information.
Code information: 471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008
Distribution pattern: US Distribution to the states of : SC, WI, RI, NY, MO, AR, OK, GA, FL, AL, CA, AZ and CO.
Derived failure modes
-
Labeling or packaging
labeling is missing