Events

Recall of Device Recall NanoTips

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
    76039
  • Event Risk Class
    Class 2
  • Event Number
    Z-1034-2017
  • Event Initiated Date
    2016-12-14
  • Event Date Posted
    2017-01-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152022
  • 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
    Syringe, restorative and impression material - Product Code EID
  • Reason
    Ultradent products, inc. announces a voluntary field action for the nanotips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe.
  • Action
    Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated December 14, 2016, to all affected consignees. The letter instructed consignees to discard remaining inventory and return the response form. For any questions, please call at 801-553-4858.

Device

Device Recall NanoTips
  • Model / Serial
    Lot Numbers: BD6KM, BCVPG, BCTBY, BD3K4, BCWVZ
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) - Internationally to Belgium, Switzerland, Germany, Italy, South Korea, Netherlands, and Japan.
  • Product Description
    NanoTips 30g 20pk, 100pk PN 1240, 1426 || Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and 0.488 in length. The cannula is secured in the base with an epoxy adhesive. Indications: Tips, when used in conjunction with the range of available syringes and products, provide a technique that is designed to provide a faster, easier, and more precise delivery. They are designed and created in such a way to generate less product waste and provide optimum control/leverage. Tips are also used for moisture removal and for directing laser light beam. Each of the tips is part of delivery systems designed for dentist-supervised, intra-oral procedures. The NanoTIp is designed for use with dental products manufactured by Ultradent Products, Inc. such as: UltraSeal XT¿ plus, UltraSeal XT¿ hydro, Ultra-Etch¿, PermaFloIdeal for microscopic restorative dentistry
  • 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