Events

Recall of Depuy Synthes Universal Battery Charger II (UBC II)

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-00175-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00175-1
  • 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 ubc ii has a component which may fail prematurely due to a manufacturing defect. if the component fails, the charger’s firmware recognises the malfunction and prevents batteries from being charged. the blue led on the front of the charger will flash to indicate that the device must be sent in for repair, in accordance with the user’s manual. when component failure occurs, the device firmware causes the ubc ii to enter “safe mode” which prevents the batteries from charging; this could potentially lead to a surgical delay.
  • Action
    JJM is advising users to quarantine any affected stock prior to return and replacement. Users are advised to use alternate chargers or non-battery operated tools until a replacement is received.

Device

Depuy Synthes Universal Battery Charger II (UBC II)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes