Events

Safety Alert for AEZ Mini Distal Cutter with Hold Long

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
    2012-07-20
  • Event Date Posted
    2012-07-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120720.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 aez mini distal cutter with hold long medical device manufacturer, ormco corporation has initiated a medical device safety alert concerning aez mini distal cutters with hold long [part no.: 803-0501; lot no.: 11m36m]. according to the manufacturer, packages labeled as long-handle cutters actually contain short-handles cutters. there are no safety or efficacy issues associated with this product. product recall and replacement is ongoing. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 july 2012.

Device

AEZ Mini Distal Cutter with Hold Long
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ormco AEZ Mini Distal Cutter with Hold Long
  • Manufacturer
    Ormco Corporation

Manufacturer

Ormco Corporation