FDA recall Z-0627-2018

Zimmer Biomet, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2017-08-25
Report date
2018-02-21
Termination date
2018-08-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0627-2018