Events

Recall of Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5(Reusable surgical instrument supplied as part of the fixation system implantation kit)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Synthes Australia 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-2013-RN-00631-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00631-1
  • 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
    Synthes australia has received complaints in relation to breakages experienced with the reduction insert and pieces during spine surgery utilising the reduction instrument for spondylolisthesis, standard, for matrix 5.5.Once the reduction insert breaks, the instrument does not function as required.
  • Action
    Synthes are requesting their customers to immediately identify and quarantine any affected units. Local sales representatives will assist in the recovery of affected devices.

Device

Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5(Reusable surgical instrument...
  • Model / Serial
    Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5(Reusable surgical instrument supplied as part of the fixation system implantation kit)Part Number: 03.632.008 All lot numbers affectedARTG Number: 155807
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd