Events

Recall of Device Recall Opal Orthodontics by Ultradent

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
    66978
  • Event Risk Class
    Class 3
  • Event Number
    Z-0481-2014
  • Event Initiated Date
    2013-11-19
  • Event Date Posted
    2013-12-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124400
  • 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
    Bracket, ceramic, orthodontic - Product Code NJM
  • Reason
    Ultradent products inc. is recalling various lots of avex cx2 orthodontic brackets because the design control process was not complete prior to distribution.
  • Action
    Ultradent Products notified consignees via email on November 19, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product. Sales representatives will pick up remaining unplaced brackets or returns will be sent back using pre-paid envelopes back to Ultradent recall coordinator for quarantine. Consignees were asked to complete evaluation forms to be returned by fax to 800-793-5206. For questions regarding this recall call 801-553-4420.

Device

Device Recall Opal Orthodontics by Ultradent
  • Model / Serial
    R&D; Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
  • Product Description
    Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets || Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
  • 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