Events

Safety Alert for TempSpan CMT

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
    2013-01-23
  • Event Date Posted
    2013-01-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130123.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: sybron dental specialties tempspan cmt medical device manufacturer, sybron dental specialties, inc., has issued a customer notification concerning all production lots within shelf life of tempspan cmt. the affected part numbers are n69ca and n69cs. the manufacturer is conducting a voluntary recall of tempspan cmt production lots that were shipped to customers since january 2011 because they may exhibit work time fluctuations and work faster than what the dfu advises. although there are no safety or efficacy issues associated with this product according to the manufacturer, product recall is ongoing. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 january 2013.

Device

TempSpan CMT
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Sybron Dental Specialties TempSpan CMT
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties