Events

Recall of Device Recall Spirit MB Brackets

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
    60118
  • Event Risk Class
    Class 3
  • Event Number
    Z-0200-2012
  • Event Initiated Date
    2011-05-18
  • Event Date Posted
    2011-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104468
  • 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
    Ormco corporation is voluntarily recalling three lots of spirit mb brackets due to a manufacturing error.
  • Action
    Ormco Corporation sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product. If any of the affected product is found, customers are directed to contact Ormco Customer Care at 1-800-854-1741 to receive a RMA number. The RMA number will allow a quick return and replacement or credit. Additionally, a Recall Return/ Acknowledgement Form was attached for customers to complete and return via fax to 909-962-5605.

Device

Device Recall Spirit MB Brackets
  • Model / Serial
    Lot #02112284
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of FL, MN, TX, and VA, and the countries of Australia, France, Germany, Italy, Japan, Mexico, Morocco, Netherlands, New Zealand, South Africa, Turkey, and Ukraine.
  • Product Description
    Spirit MB Brackets, part #494-1210. || The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment.
  • Manufacturer
    Ormco Corporation

Manufacturer

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