BEUDAMED
    FDA Enforcement Class II Completed

    ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101

    Recall: Z-2287-2023 · Reported August 9, 2023

    Enforcement

    Recall Number
    Z-2287-2023
    Event ID
    92732
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Materialise N.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 9, 2023
    Initiation Date
    June 19, 2023
    Classification Date
    August 3, 2023
    Address
    Technologielaan 15, N/A, Heverlee, N/A, N/A, Belgium

    Description

    ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101

    Reason

    Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

    Code Info

    UDI: 05420060351013 Lot Case Number: MU23-JOQ-LID

    Distribution

    US Nationwide distribution in the state of KY.

    Quantity

    1 unit