BEUDAMED
    FDA Enforcement Class II Terminated

    Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089

    Recall: Z-0512-2022 · Reported January 26, 2022

    Enforcement

    Recall Number
    Z-0512-2022
    Event ID
    89321
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Straumann USA LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 26, 2022
    Initiation Date
    November 30, 2021
    Classification Date
    January 19, 2022
    Termination Date
    February 5, 2025
    Address
    60 Minuteman Rd, N/A, Andover, MA, 01810-1008, United States

    Description

    Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089

    Reason

    Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant

    Code Info

    Lot GNV17 UDI: 7899878052722

    Distribution

    US Nationwide Distribution in the states of FL, IL, OH

    Quantity

    7 pieces