Events

Safety Alert for PREMISA Unidose Refills - A3.5

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Kerr 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
    2017-02-02
  • Event Date Posted
    2017-02-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170202.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: kerr corporation premisa unidose refills - a3.5 medical device manufacturer, kerr corporation, has issued a medical device safety alert concerning its premisa unidose refills - a3.5 (part number: 32814; lot number: 5641195; shipped between november 2015 to december 2015) it has recently come to the manufacturer’s attention that an issue with the production process used to package the affected lots of premisa may lead to the presence of plastic particulates in the dental composite material. the particulate is visible to doctors and should be easy to remove prior to or even after curing. furthermore, the particulate is unlikely to cause any adverse health consequences. there is no need to replace any restorations placed with this material. product recall and replacement is on-going. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 2 february 2017.

Device

PREMISA Unidose Refills - A3.5
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Kerr Corporation PREMISA Unidose Refills - A3.5
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation