BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055

    Recall: Z-0084-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0084-2021
    Event ID
    86424
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2020
    Initiation Date
    September 4, 2020
    Classification Date
    October 8, 2020
    Termination Date
    August 31, 2021
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055

    Reason

    Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

    Code Info

    Lot Numbers: 894660A 894660B 894670B 894700B

    Distribution

    Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM

    Quantity

    4 units OUS