Events

Recall of ROTAIO Cervical Disc Prosthesis

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-01457-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01457-1
  • 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
    In the postoperative course patients reported a temporary or permanent development of noise. concerned were approx. 0.12 % of the disc prostheses. in some individual cases the doctors in charge decided to remove the implant. extensive analyses by the manufacturer, signus medizintechnik has not identified any indications as to the causes of the noise development as yet. examinations of implants removed and reference implants performed in that context showed that the prostheses were properly manufactured and fully functional with no structural defects or abnormal signs of wear and tear.
  • Action
    The manufacturer is adding the possible side effect “temporary or permanent noise development” in the Instructions For Use (IFU).

Device

ROTAIO Cervical Disc Prosthesis

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia