Events

Safety Alert for Electric Pen Drive

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

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
    2013-01-21
  • Event Date Posted
    2013-01-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130121.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: synthes electric pen drive medical device manufacturer, synthes, has initiated a field safety corrective action concerning the hand switch for electric pen drive [part no.: 05.001.012; lot no.: av19044, av18166, av20666]. the manufacturer has received one complaint about a hand switch, for electric pen drive not labeled correctly ("on" and "lock" labels interchanged). synthes advises users to inspect the device and inform them for replacement if detected faulty devices. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions. posted on 21 january 2013.

Device

Electric Pen Drive
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes Electric Pen Drive
  • Manufacturer
    Synthes

Manufacturer

Synthes