Events

Recall of Integra Mayfield Ultra 360 Base Unit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Integra Neurosciences 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-2015-RN-00052-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00052-1
  • 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
    Mayfield ultra 360 base units may experience a failure of the locking system during use due to the excessive clearance between the inner diameter (bore) of the cam rod and the mating post that may potentially result in adverse patient health consequence in the event a breakage occurs during neurosurgical use.No complaint reports have been received in australia or new zealand.
  • Action
    Customers are to be alerted to this issue and are advised to discontinue use of the device until lntegra verifies their device does not have excessive clearance or if it does, the excessive clearance is corrected. This action has been closed-out on 19/08/2016.

Device

Integra Mayfield Ultra 360 Base Unit

Manufacturer

Integra Neurosciences Pty Ltd