BEUDAMED
    FDA Enforcement Class II Terminated

    Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.

    Recall: Z-0924-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0924-2020
    Event ID
    84709
    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
    February 12, 2020
    Initiation Date
    December 23, 2019
    Classification Date
    January 31, 2020
    Termination Date
    June 1, 2021
    Address
    Av Juscelino Kubitschek De Oliveira, N/A, Curitiba, N/A, N/A, Brazil

    Description

    Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.

    Reason

    The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".

    Code Info

    Lot WH723

    Distribution

    Distributed to consignees in CA and PA.

    Quantity

    2