Events

Safety Alert for Buchanan Medium Pluggers

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

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
    2012-02-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120223a.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
    Field safety notice: sybronendo buchanan medium pluggers medical device manufacturer, sybron dental specialties, inc., has issued a field safety notice concerning the recall of certain lots of buchanan medium pluggers. the manufacturer found that some lots of buchanan pluggers labeled as medium were assembled with fine medium tips instead of the correct medium tips. according to the manufacturer, the product will be able to reach appropriate proximity to the apex and therefore function as expected. there are no safety or efficacy issues associated with this assembly error. sybron dental specialties reported that there are no hong kong consignees being affected by this recall. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Buchanan Medium Pluggers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: SybronEndo Buchanan Medium Pluggers
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties