Events

Safety Alert for clinical tempspan cmt

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

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
    2012-08-29
  • Event Date Posted
    2012-08-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120829a.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: pentron clinical tempspan cmt medical device manufacturer, pentron clinical, has issued a medical device safety alert concerning tempspan cmt [part no. n69ca]. the manufacturer would also like to inform users that the current directions for use (dfu) for tempspan cmt lists a working time specification that is not indicative of the actual performance of the product. the current dfu lists the minimum working time as 60 seconds; however, the following timing parameters should be followed when using tempspan cmt there are no safety or efficacy concerns associated with tempspan cmt as the product will set. product tempspan cmt minimum working time 45 seconds maximum intra oral setting time (from initial mix) 3 minutes 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 29 august 2012.

Device

clinical tempspan cmt
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Pentron Clinical TempSpan CMT
  • Manufacturer
    Pentron Clinical

Manufacturer

Pentron Clinical