Device product
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
Z-0628-2018
Product summary
- Event
- Event 79095
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 devices
- Official record key
device-enforcement:Z-0628-2018
Official wording
Reason: The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Code information: Model No. 150804: Lot No. 088080 ((01)00880304240247(17)220606(10)088080), 305410 ((01)00880304240247(17)220601(10)305410).
Distribution pattern: US Nationwide Distribution to IN, MO, NY, TX.
Derived failure modes
-
Unknown
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.