Events

Recall of Device Recall NEODENT CM Intraoral Scanbody

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instradent USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76843
  • Event Risk Class
    Class 2
  • Event Number
    Z-1831-2017
  • Event Initiated Date
    2017-03-13
  • Event Date Posted
    2017-04-07
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154385
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accessories, implant, dental, endosseous - Product Code NDP
  • 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.

Device

Device Recall NEODENT CM Intraoral Scanbody
  • Model / Serial
    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.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.
  • Product Description
    NEODENT CM Intraoral Scanbody, Article Number: 108.139
  • Manufacturer
    Instradent USA, Inc.

Manufacturer

Instradent USA, Inc.
  • Manufacturer Address
    Instradent USA, Inc., 60 Minuteman Rd, Andover MA 01810-1008
  • Manufacturer Parent Company (2017)
    Straumann Holding AG
  • Source
    USFDA