Events

Recall of Damon 3 Bracket || Upper Right lateral .022 slot || Part Number 491-4211 || Lot Number 100514071 and 100512012

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ormco Corporation.

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
    34016
  • Event Risk Class
    Class 2
  • Event Number
    Z-0204-06
  • Event Initiated Date
    2005-11-03
  • Event Date Posted
    2005-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42911
  • 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, Plastic, Orthodontic - Product Code DYW
  • Reason
    Two part numbers of damon 3 brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving fda 510k market clearance.
  • Action
    Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.

Device

Damon 3 Bracket || Upper Right lateral .022 slot || Part Number 491-4211 || Lot Number 100514071 ...
  • Model / Serial
    Lot Number 100514071 and 100512012
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Damon 3 Bracket || Upper Right lateral .022 slot || Part Number 491-4211 || Lot Number 100514071 and 100512012
  • Manufacturer
    Ormco Corporation

Manufacturer

Ormco Corporation
  • Manufacturer Address
    Ormco Corporation, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • Source
    USFDA