Events

Recall of Device Recall Copper NiTi Preformed Archwires

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
    72590
  • Event Risk Class
    Class 2
  • Event Number
    Z-0343-2016
  • Event Initiated Date
    2015-11-04
  • Event Date Posted
    2015-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141617
  • 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
    Wire, orthodontic - Product Code DZC
  • Reason
    Ormco corporation is recalling copper niti preformed archwires because the product transformation temperature as listed on the labeling is incorrect.
  • Action
    A recall letter dated 11/5/15 was sent to all their customers who purchased the Copper NiTi Preformed Archwires because it has been brought to Ormco's attention that the product transformation temperature as listed on the labeling is incorrect. The wire is labeled as having 40 degrees Celsius transformation temperature, but the actual wire has a transformation temperature of 29 degrees Celsius. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to complete and fax back the enclosed acknowledgement form.

Device

Device Recall Copper NiTi Preformed Archwires
  • Model / Serial
    Lot No. 21538339
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
  • Product Description
    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
  • 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