Device product

AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.

Z-0627-2018

August 25, 2017

Class II

Product summary

Firm: Zimmer Biomet, Inc.
Event: Event 79095
Status: Terminated
Classification: Class II
Quantity: 28 devices
Official record key: device-enforcement:Z-0627-2018

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. 150802: Lot No. 305330 (UDI (01)00880304240230(17)220506(10)305330), 305340 ((01)00880304240230(17)220506(10)305330), 305350 ((01)00880304240230(17)220517(10)305350), 356750 ((01)00880304240230(17)220523(10)356750).

Distribution pattern: US Nationwide Distribution to IN, MO, NY, TX.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.