BEUDAMED
    FDA Enforcement Class II Terminated

    NEODENT CM Intraoral Scanbody, Article Number: 108.139

    Recall: Z-1831-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1831-2017
    Event ID
    76843
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instradent USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2017
    Initiation Date
    March 13, 2017
    Classification Date
    April 17, 2017
    Termination Date
    February 28, 2019
    Address
    60 Minuteman Rd, N/A, Andover, MA, 01810-1008, United States

    Description

    NEODENT CM Intraoral Scanbody, Article Number: 108.139

    Reason

    During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned.

    Code Info

    Lot Numbers: 800.214.016, 800.217.067, 56.390, 63.224, 71.065, 71.066, 71.067, 71.068, 71.069, and 71.070.

    Distribution

    Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.

    Quantity

    170 pieces