BEUDAMED
    FDA Enforcement Class II Terminated

    AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.

    Recall: Z-0628-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0628-2018
    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 Med, Model Number 150804. 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. 150804: Lot No. 088080 ((01)00880304240247(17)220606(10)088080), 305410 ((01)00880304240247(17)220601(10)305410).

    Distribution

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

    Quantity

    11 devices