Events

Recall of Device Recall Avex CX Suite

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
    64303
  • Event Risk Class
    Class 3
  • Event Number
    Z-0876-2013
  • Event Initiated Date
    2013-02-08
  • Event Date Posted
    2013-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115785
  • 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, metal, orthodontic - Product Code EJF
  • Reason
    Orthodontic brackets distributed was incorrectly labeled.
  • Action
    Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 8 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to return affected products for replacement. Customers with questions can call firm representative, Corey Jaseph at (801) 553-4220.

Device

Device Recall Avex CX Suite
  • Model / Serial
    Lot R131360
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including the states of CA, AZ, CO and WA.
  • Product Description
    Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, || Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.
  • 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