BEUDAMED
    FDA Enforcement Class II Completed

    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

    Recall: Z-1569-2022 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1569-2022
    Event ID
    90704
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Materialise USA LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 31, 2022
    Initiation Date
    July 13, 2022
    Classification Date
    August 24, 2022
    Address
    44650 Helm Ct, Plymouth, MI, 48170-6061, United States

    Description

    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

    Reason

    MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK

    Code Info

    Unique Device Identifier (01)05420060352089(10)MU22INADUQ Lot Number: MU22-INQ-DUQ

    Distribution

    US Nationwide distribution in the state of MD.

    Quantity

    1 unit