Events

Recall of Ormco Damon TMA Low Friction Archwire

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    16916
  • Event Initiated Date
    2014-07-08
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Law and Accounting Professional Trustees Limited, 336, Jackson Street, Petone
  • Reason
    The product labeling descriptor on the package for damon tma low friction archwires references dimensions that are different from those of the actual wire. the label states that the wire dimension is .017x.020, however the actual dimension is .017x.025. although the product description on the label is incorrect, the part number, lot number, product packaging and the product within the package are correct.
  • Action
    Manufacturer to issue advice regarding use

Device

Ormco Damon TMA Low Friction Archwire
  • Model / Serial
    Model: Part Number: 227-1112, Affected: Lot Number: 031430923
  • Manufacturer
    Ormco Corporation

Manufacturer

Ormco Corporation