Events

Recall of Device Recall Chromaclone PVS Heavy (Regular Set)

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
    64272
  • Event Risk Class
    Class 3
  • Event Number
    Z-0811-2013
  • Event Initiated Date
    2013-02-04
  • Event Date Posted
    2013-02-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115759
  • 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
    Material, impression - Product Code ELW
  • Reason
    Incorrect packaging of regular set and fast set cartridges.
  • Action
    Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected products. They may continue to use product or dispose unwanted cartridges and reply back to firm indicating acknowledgement of letter and if replacement is needed. Consumers with questions can call the firm at 801-553-4420. For questions regarding this recall call 801-553-4420.

Device

Device Recall Chromaclone PVS Heavy (Regular Set)
  • Model / Serial
    Part No. 5012, Lot No. B7PPC
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
  • Manufacturer
    Ultradent Products, Inc.

Manufacturer

Ultradent Products, Inc.
  • Manufacturer Address
    Ultradent Products, Inc., 505 W 10200 S, South Jordan UT 84095-3935
  • Manufacturer Parent Company (2017)
    Ultradent Products Inc
  • Source
    USFDA