BEUDAMED
    FDA Recall Completed

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

    Recall: Z-1569-2022 · Initiated July 13, 2022

    Recall

    Recall Number
    Z-1569-2022
    Event Number
    90704
    Firm
    Materialise USA LLC
    FEI Number
    3005718816
    Product Code
    HWT
    Status
    Completed
    Root Cause
    Employee error
    Initiated
    July 13, 2022
    Address
    44650 Helm Ct, Plymouth, MI, 48170-6061

    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

    Action

    Materialise USA LLC notified field representative via telephone on 13 July 2022 requesting the case to be returned. A replacement case was sent on 14 July 2022. Materialise picked up/received MU22-INQ-DUQ case with anatomical model MU22-NOF-SAK on 22 July 2022. This recall can be terminated as all distributed product (one case) has been returned to Materialise. No additional product remains in the field.

    Distribution

    US Nationwide distribution in the state of MD.

    Quantity

    1 unit