Events

Recall of Device Recall Spirit MB Bracket

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
    67849
  • Event Risk Class
    Class 2
  • Event Number
    Z-1330-2014
  • Event Initiated Date
    2014-03-25
  • Event Date Posted
    2014-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126492
  • 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 initiated this recall of spirit mb brackets, part number 494-0110, lot number 081351013, because the id dot, which designates the bracket as distal/gingival, is misplaced. the misidentification may lead an orthodontist to place the bracket on the wrong tooth, leading to movement 10 degrees in the wrong direction.
  • Action
    Ormco Corporation initiated this recall by sending recall letters to customers on March 25, 2014 via 1st class mail. The letter identified the affected product, problem and actions to be taken. The consignees are instructed to complete the "Return Form" and return any affected product in their inventory. The letter was written in Japanese language and accompanied by a "Return Form".

Device

Device Recall Spirit MB Bracket
  • Model / Serial
    Part Number 494-0110, Lot Number 081351013.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Internationally Distributed in the country of Japan.
  • Product Description
    Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. || Product Usage: An orthodontic bracket. Spirit MB Brackets are 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