FDA-Device2018-02-21Class II
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
Zimmer Biomet, Inc.
Hazard
The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.
Sold states
US Nationwide Distribution to IN, MO, NY, TX.
Affected count
28 devices
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0627-2018Don't want to check this manually?
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