Events

Safety Alert for Enlight Unidose

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Ormco Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-05-17
  • Event Date Posted
    2012-05-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120517a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: ormco enlight unidose medical device manufacturer, ormco corporation, is conducting a recall on one lot of enlight unidose as the result of a mispackaging error. sybron dental specialties, inc. (sds), a company representing ormco corporation, reported that the product labeled as enlight unidose actually contained enlight syringes andthere are no safety or efficacy issues associated with this mispackaging error. according to sdss, the affected devices were not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 17 may 2012.

Device

Enlight Unidose
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ormco Enlight Unidose
  • Manufacturer
    Ormco Corporation

Manufacturer

Ormco Corporation