Events

Safety Alert for Adapter for Colibri and small Adapter for Colibri II and Small Battery Drive and Small Battery Drive II

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
    2016-07-18
  • Event Date Posted
    2016-07-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160718b.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 adapter for colibri and small adapter for colibri ii and small battery drive and small battery drive ii medical device manufacturer, synthes, has issued a medical device safety alert concerning the following devices: adapter for colibri for electric pen drive; b) adapter, small, for colibri (ii) and small battery drive (ii) part number: a) 05.001.024 and b) 05.001.108 according to the manufacturer, there is a potential for the adapter for colibri and small adapter for colibri ii and small battery drive and small battery drive ii to generate excessive internal pressure that may cause the respective products to burst. the captioned device could cause permanent injury to the user and/or patient. although preliminary internal tests for this failure mode have determined this scenario is highly unlikely to occur, the manufacturer has decided to remove these products from the field. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 july 2016.

Device

Adapter for Colibri and small Adapter for Colibri II and Small Battery Drive and Small Battery Dr...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Synthes Adapter for Colibri and small Adapter for Colibri II and Small Battery Drive and Small Battery Drive II
  • Manufacturer
    Synthes

Manufacturer

Synthes