BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Regenerex Primary Taper Cap Item Number 141269

    Recall: Z-0081-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0081-2021
    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 Regenerex Primary Taper Cap Item Number 141269

    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: 015800 324440 685300 023900 324440R 696280 058930 389060 821980 200720 418430 890320 313260 646040 997610

    Distribution

    Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM

    Quantity

    US: 62 units; OUS: 176 units