Events

Recall of BROAD ARCH

According to Health Canada (via FOI), this recall involved a device in Canada 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
    147628
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-02
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The product transformation temperature as listed on the labelling is not correct. the wire is labelled as having a 40c transformation temperature but the actual wire has a transformation temperature of 29c.

Device

BROAD ARCH
  • Model / Serial
    Model Catalog: 211-0952 (Lot serial: 021538339)
  • Product Description
    COPPER NITI PREFORMED ARCHWIRE 40C .016X .022 LO PK 10
  • Manufacturer
    ORMCO CORPORATION

Manufacturer

ORMCO CORPORATION