BEUDAMED
    FDA Recall Terminated

    NEODENT CM Intraoral Scanbody, Article Number: 108.139

    Recall: Z-1831-2017 · Initiated March 13, 2017

    Recall

    Recall Number
    Z-1831-2017
    Event Number
    76843
    Firm
    Instradent USA, Inc.
    FEI Number
    1000121052
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 13, 2017
    Posted
    April 7, 2017
    Terminated
    February 28, 2019
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    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.

    Action

    Instradent sent an Urgent Field Safety Notice dated March 13, 2017, to all affected customers via UPS. Customers were asked to take the following actions: 1. Identify and segregate the affected units from your stock. 2. If the product is still in your Inventory, return it for credit. 3. If you have used the product successfully, there is no need to take any action 4. For all cases complete and return the enclosed Customer Confirmation Form. For further questions, please call (855) 412-8883.

    Distribution

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

    Quantity

    170 pieces