BEUDAMED
    FDA Enforcement Class II Terminated

    Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

    Recall: Z-0019-2020 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-0019-2020
    Event ID
    83198
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Paltop Advanced Dental Solutions Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 9, 2019
    Initiation Date
    May 30, 2019
    Classification Date
    October 1, 2019
    Termination Date
    June 9, 2020
    Address
    5, Ha-Shita, N/A, Caesarea, N/A, N/A, Israel

    Description

    Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

    Reason

    Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.

    Code Info

    Lot Number: W0-008254 UDI: 729010869611020-70024P

    Distribution

    AL AZ CA CO FL GA MA MD MO MT NJ NM NY OH SC VA

    Quantity

    167 units