Events

Recall of NAJA Spinal Ligament Systems for Spinal Stabilization

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Evolution Surgical 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-2018-RN-00007-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00007-1
  • 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, cousin biotech, through post-market surveillance systems has identified three successive cases of breakage of the metal connector clamping system that occurred during surgery. for these three incidents, there were no serious clinical outcomes for patients except a slight increase in operating time to use another medical device.
  • Action
    1. The letter should be passed on to end-users, to all persons concerned in your company, or to any other organization (healthcare centers) to which potentially affected products have been sent. 2. Check stock and quarantine all unused devices with the batch numbers identified. 3. Complete the supplied form and return it to the email address provided for the sponsor to arrange the collection of affected units.

Device

NAJA Spinal Ligament Systems for Spinal Stabilization
  • Model / Serial
    NAJA Spinal Ligament Systems for Spinal StabilizationReference Numbers: RCBNAJ55LU, RCBNAJ55RUBatch Numbers - 141527, 141724, 141896, 151605, 151940, 151939, 152079, 152319, 171823, 170696, 172044, 151604, 152080ARTG Number: 273278 (Evolution Surgical Pty Ltd - Spinal internal fixation system, intervertebral body)
  • Manufacturer
    Evolution Surgical Pty Ltd

Manufacturer

Evolution Surgical Pty Ltd
  • Source
    DHTGA