BEUDAMED
    FDA Enforcement Class II Ongoing

    MAGEC 1 System

    Recall: Z-0528-2022 · Reported February 2, 2022

    Enforcement

    Recall Number
    Z-0528-2022
    Event ID
    89177
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NuVasive Specialized Orthopedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 2, 2022
    Initiation Date
    June 25, 2019
    Classification Date
    January 26, 2022
    Address
    101 Enterprise Ste 100, Aliso Viejo, CA, 92656-2604, United States

    Description

    MAGEC 1 System

    Reason

    Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.

    Code Info

    All MAGEC Systems (Serial/Lot Numbers) manufactured prior to March 26, 2015.

    Distribution

    Worldwide

    Quantity

    3,056 devices