Events

Recall of SerenoCem Granules BCG050 (Orthopaedic bone cement)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Endotherapeutics 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-00439-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00439-1
  • 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, corinthian surgical ltd has been made aware of a cluster of cases in the united kingdom where it has been observed that there has been some bone re- absorption in the area adjacent to the granules in the middle ear. this can lead to exposure of the dura and facial nerve, potentially resulting in infection and/or brain herniation. as a precautionary measure corinthian surgical ltd is temporally suspending the supply of serenocem granules and there should be no further use of the granules at this time. the cause of the reported cases of bone resorption is currently under investigation.
  • Action
    Endotherapeutics is recommending that if a patient presents for a routine checkup or at the 2 yearly follow up, to perform a CT scan. Outside of these circumstances, patients should undergo a CT scan at the clinical discretion of the treating surgeon. Any remaining unused stock should be quarantined and returned to Endotherapeutics. The investigation is currently ongoing, and further communications may be required following completion of the investigation and in consultation with the Therapeutic Goods Administration (TGA).

Device

SerenoCem Granules BCG050 (Orthopaedic bone cement)
  • Model / Serial
    SerenoCem Granules BCG050 (Orthopaedic bone cement)All lots affectedARTG Number: 152441
  • Manufacturer
    Endotherapeutics Pty Ltd

Manufacturer

Endotherapeutics Pty Ltd