BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0924-2020 · Initiated December 23, 2019

    Recall

    Recall Number
    Z-0924-2020
    Event Number
    84709
    Firm
    Jjgc Industria E Comercio De Materials Dentarios Sa Av Juscelino Kubitschek De Oliveira Curitiba Brazil
    FEI Number
    3008261720
    Product Code
    EJL
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 23, 2019
    Posted
    January 30, 2020
    Terminated
    June 1, 2021

    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".

    Action

    Customers were notified of the recall on 12/23/2019 via telephone and email. Customers were instructed to do the following: - If the clinician has already used the drill for osteotomy and successfully concluded the installation of the implant, additional patient follow-up not required. The implant will behave as normally expected. - Identify and segregate the affected units, opened or unopened, in your stock. - If the product is still in your inventory, return it to the attention of "Action 0002/2019 Product Removal" for credit as indicated on ANNEX 1: Customer Confirmation Form. - If the product cannot be located, indicate this on the Customer Confirmation Form. - For either case, complete and return the Customer Confirmation Form to "Action 0002/2019 Product Removal"

    Distribution

    Distributed to consignees in CA and PA.

    Quantity

    2