Events

Recall of Ultradent Products, Inc. Paper Points

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ultradent Products, 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
    77891
  • Event Risk Class
    Class 2
  • Event Number
    Z-3217-2017
  • Event Initiated Date
    2017-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158143
  • 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
    Point, paper, endodontic - Product Code EKN
  • Reason
    The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
  • Action
    The recalling firm issued letters dated August 4, 2017 via certified mail,2-day delivery mail, or email on August 4, 2017. The letter identified the affected product, problem, and actions to be taken. For questions contact Regulatory Affairs Specialist at Ultradent Products, Inc.

Device

Ultradent Products, Inc. Paper Points
  • Model / Serial
    Lot numbers BDB9Q, BDHWK, BDTBJ, and BDX3F
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
  • Product Description
    Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile. || Product Usage: || The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins..
  • Manufacturer
    Ultradent Products, Inc.

Manufacturer

Ultradent Products, Inc.
  • Manufacturer Address
    Ultradent Products, Inc., 505 W 10200 S, South Jordan UT 84095-3800
  • Manufacturer Parent Company (2017)
    Ultradent Products Inc
  • Source
    USFDA