BEUDAMED
    FDA Enforcement Class II Terminated

    Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

    Recall: Z-0028-2020 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-0028-2020
    Event ID
    83385
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Voco GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 9, 2019
    Initiation Date
    July 9, 2019
    Classification Date
    October 1, 2019
    Termination Date
    April 20, 2023
    Address
    Anton-Flettner-Str. 1-3, N/A, Cuxhaven, N/A, N/A, Germany

    Description

    Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

    Reason

    The metal cannula are potentially too loose and may become loose when applying the filing material.

    Code Info

    Item Number 2706; Lot Number 1923282; Expiration Date 12/28/2021

    Distribution

    Distributed in the US to Iowa and New York

    Quantity

    5 units