Events

Recall of Adapter for Colibri, Electric Pen Drive and Light Adapter for Colibri and Colibri II hand piece

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00964-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00964-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the electric pen drive (epd) system to operate the colibri and colibri ii with the epd consoles. the adaptor can be inserted into the colibri or colibri ii handpiece and removed like a battery pack.There is a potential for the adapter for colibri and adapter for colibri ii to generate excessive internal pressure that may cause the respective products to burst. preliminary tests for this failure mode by the manufacturer have determined this scenario is highly unlikely to occur. there have been no injuries as a result of this issue.
  • Action
    JJM is advising users to inspect stock and quarantine any units of the affected adapters. The Colibri Drill system is able to be operated by the use of specific batteries; listed below. These products will be made available. • Universal battery charger, Product 05.001.204 • Battery case, Product 532.132 • 14.4V Lithium-Ion battery Product 532.103 • Sterile transfer product 532.104

Device

Adapter for Colibri, Electric Pen Drive and Light Adapter for Colibri and Colibri II hand piece
  • Model / Serial
    Adapter for Colibri, Electric Pen Drive and Light Adapter for Colibri and Colibri II hand pieceAdapter for Colibri, Electric Pen DriveProduct Number: 05.001.024Light Adapter for Colibri and Colibri II hand pieceProduct Number: 05.001.108All lots affectedARTG Number: 157072
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes