BEUDAMED
    FDA Enforcement Class II Terminated

    GM Helix Acqua Implant 3.5x10, Article No. 140.944

    Recall: Z-0203-2022 · Reported November 10, 2021

    Enforcement

    Recall Number
    Z-0203-2022
    Event ID
    88917
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Jjgc Industria E Comercio De Materials Dentarios Sa
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 10, 2021
    Initiation Date
    October 11, 2021
    Classification Date
    November 4, 2021
    Termination Date
    January 16, 2024
    Address
    Av Juscelino Kubitschek De Oliveira, N/A, Curitiba, N/A, N/A, Brazil

    Description

    GM Helix Acqua Implant 3.5x10, Article No. 140.944

    Reason

    3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.

    Code Info

    UDI 7899878024897 Lots GNW15 and GRE82

    Distribution

    US Nationwide distribution.

    Quantity

    567 (US)