Events

Recall of Device Recall UltraSeal XT Plus Clear Refill

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
    75796
  • Event Risk Class
    Class 2
  • Event Number
    Z-0704-2017
  • Event Initiated Date
    2016-11-17
  • Event Date Posted
    2016-12-03
  • 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=151291
  • 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
    Sealant, pit and fissure, and conditioner - Product Code EBC
  • Reason
    There was a labeling error with product, ultraseal xt plus clear refill, part number (pn) 565, lot number (lot) bd79t. the package was mislabeled as pq1, pn 641; while the barcode, ifu and products were labeled for ultraseal xt plus clear refill, pn 565, lot bd79t.
  • Action
    Consignees notified via phone on 17Nov2016 and by letter on 22Nov2016 to identify and return products. Consignees with any questions regarding this field action can be sent to 801-553-4858 or 801-553-4220.

Device

Device Recall UltraSeal XT Plus Clear Refill
  • Model / Serial
    Lot BD79T
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. || Product Usage: || The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.
  • 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