Events

Recall of Neuro Flap Fix Kit (used for fixation of cranial bone flaps and fractures)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life Healthcare Pty Ltd.

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-01497-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01497-1
  • 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 manufacturer has received a report from a user advising that the secondary peel bag of the sterile packaged article was not completely sealed. an incorrect welding process has resulted in the secondary peel bag not being sealed. a non-welded secondary peel bag results in the primary bag becoming no longer sterile and thus a “non-sterile article” can reach the sterile area of the operating room. this presents a potential safety risk for the patient. the manufacturer is not aware of any other incidents, however the affected batch is being recalled as a precaution.
  • Action
    LifeHealthcare is advising customers to quarantine affected stock and to contact LifeHealthcare to arrange for collection and replacement. This action has been closed-out on 18/05/2017.

Device

Neuro Flap Fix Kit (used for fixation of cranial bone flaps and fractures)
  • Model / Serial
    Neuro Flap Fix Kit (used for fixation of cranial bone flaps and fractures)Product Code: 25-302-10-71Lot Number: 33173390ARTG Number: 202843
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd