BEUDAMED
    FDA Enforcement Class II Ongoing

    ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B

    Recall: Z-1604-2023 · Reported May 24, 2023

    Enforcement

    Recall Number
    Z-1604-2023
    Event ID
    92272
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Hiossen Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 24, 2023
    Initiation Date
    April 6, 2023
    Classification Date
    May 18, 2023
    Address
    Keystone Industrial Port Complex, 85 Ben Fairless Dr, Fairless Hills, PA, 19030-5012, United States

    Description

    ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B

    Reason

    Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm

    Code Info

    UDI-DI: 00814913023717 Lot Number: H1E22J263

    Distribution

    US Nationwide Distribution

    Quantity

    287 units