Events

Safety Alert for 3M ESPE IMPRINT II Regular Body VPS Impression Material Refill

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by 3M ESPE Dental Products.

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
    2013-12-04
  • Event Date Posted
    2013-12-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131204.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: 3m espe imprint ii regular body vps impression material refill medical device manufacturer, 3m espe dental products, has issued a medical device safety alert concerning its imprint ii regular body vps impression material refill 4-pack [catalogue number: 9379; lot number: n510884 and n510889]. the manufacturer is conducting a voluntary recall of the above affected products. the reason for the recall of this product is that the moisture displacement feature is greatly reduced, which may impact the quality of a dental impression. the manufacturer will arrange for return and replacement of affected products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 december 2013.

Device

3M ESPE IMPRINT II Regular Body VPS Impression Material Refill
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: 3M ESPE IMPRINT II Regular Body VPS Impression Material Refill
  • Manufacturer
    3M ESPE Dental Products

Manufacturer

3M ESPE Dental Products