BEUDAMED
    FDA Enforcement Class II Terminated

    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.

    Recall: Z-0577-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0577-2014
    Event ID
    66935
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Materialise USA LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 1, 2014
    Initiation Date
    November 8, 2013
    Classification Date
    December 26, 2013
    Termination Date
    January 7, 2014
    Address
    44650 Helm Ct, N/A, Plymouth, MI, 48170-6061, United States

    Description

    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.

    Reason

    Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.

    Code Info

    Item reference SD900.106; Unique Instrument ID MC13-OVA-OGO_01

    Distribution

    Distributed in Canada.

    Quantity

    1