BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050

    Recall: Z-0082-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0082-2021
    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 OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050

    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: 868570A 868670A 869650A 869710B 869770A 880720B 926610B 941910A 868570B 868670B 869650B 869720A 869770B 880730A 926620A 941910B 868590A 868680A 869660A 869720B 869780B 880730B 926620B 941920A 868610A 868680B 869660B 869730A 869790B 926570A 926630A 941920B 868610B 868690A 869680B 869730B 880610B 926570B 926630B 941930B 868640A 868690B 869690A 869740A 880700A 926580B 926640A 942010B 868650A 868700A 869690B 869740B 880710A 926590A 926640B 942030B 868650B 868700B 869700A 869750A 880710B 926600A 941900A 942040A 868660A 868710A 869700B 869750B 880720A 926610A 941900B 942040B 868660B 868710B 869710A 869760B

    Distribution

    Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM

    Quantity

    80 units US