BEUDAMED
    FDA Enforcement Class II Ongoing

    Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01

    Recall: Z-0569-2024 · Reported December 27, 2023

    Enforcement

    Recall Number
    Z-0569-2024
    Event ID
    93486
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 27, 2023
    Initiation Date
    November 2, 2023
    Classification Date
    December 18, 2023
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01

    Reason

    One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.

    Code Info

    UDI-DI: 00889024430556; Lot Number: 3145299

    Distribution

    US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.

    Quantity

    10 units