Events

Recall of Device Recall Titanium Orthos Brackets

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

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
    67861
  • Event Risk Class
    Class 2
  • Event Number
    Z-1321-2014
  • Event Initiated Date
    2014-03-25
  • Event Date Posted
    2014-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126506
  • 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
    Metal orthodontic bracket - Product Code EJF
  • Reason
    Ormco corporation inititated recall of u2r titanium orthos (0.22+9/+9/0), part number 449-6212, lot number 121359169, because the color id dot was marked on the wrong tie-wing of the brackets.
  • Action
    Recall notification letters sent to all affected consignees via 1st class mail on March 24, 2014. The consignees are instructed to complete the Return Form and have the option to return any affected product in their inventory to Ormco Corporation. The letter is dated "March 24, 2014" and titled: "URGENT: MEDICAL DEVICE RECALL". The letter informed customers of the recall, reason for recall, product description with part number and lot number, instructions to follow, and contact information. The letter was accompanied by a "Recall Return/Acknowledgement Form".

Device

Device Recall Titanium Orthos Brackets
  • Model / Serial
    Part Number 449-6212, Lot Number 121359169.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US and Canada.
  • Product Description
    Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.
  • Manufacturer
    Ormco/Sybronendo

Manufacturer

Ormco/Sybronendo
  • Manufacturer Address
    Ormco/Sybronendo, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA