BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0627-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0627-2018
    Event ID
    79095
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    August 25, 2017
    Classification Date
    February 15, 2018
    Termination Date
    August 9, 2018
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

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

    Reason

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

    Code Info

    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

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

    Quantity

    28 devices