Events

Safety Alert for TF Adaptive Gutta Percha Point Size SM3-50pk

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Ormco 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
    2016-02-18
  • Event Date Posted
    2016-02-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160218a.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: ormco corporation tf adaptive gutta percha point size sm3-50pk medical device manufacturer, ormco corporation, has issued a medical device safety alert concerning its tf adaptive gutta percha point size sm3-50pk. [part number: 815-1541; lot number: ge15011637]. the manufacturer has become aware of a mismatch of the above product’s inner and outer labels. the outer package of the product is identified as sm3, which matches the product inside. however, the inner generic label is identified as ml3. according to the manufacturer, this product would be used correctly in a properly obturated canal. if a doctor removed the cover of the tray and is only looking at the inner label, he could mistakenly use the sm gutta percha with a ml file system. this sm3 gp will not properly fill the canal due to smaller size and can result in the gutta percha slipping past the apex of the root. product recall is on-going. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 february 2016.

Device

TF Adaptive Gutta Percha Point Size SM3-50pk
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ormco Corporation TF Adaptive Gutta Percha Point Size SM3-50pk
  • Manufacturer
    Ormco Corporation

Manufacturer

Ormco Corporation