Events

Recall of Small Pedicle Probe ELL-IN 02 23-N

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Spineart 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-2018-RN-00087-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00087-1
  • 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
    Spineart australia has been made aware that there is a non conformance on the graduation of the device. the graduation is 30/40/45/60 mm instead of 30/40/50/60 mm. investigation from the sponsor has determined that this engraving error comes from the etching step during manufacturing and had not been caught duing the manufacturers control step. no other batches of the same reference are affected by this issue.There have been no reported events as a reuslt of this issue.This action was undertaken prior to consultation with the therapeutic goods adminsitration (tga).
  • Action
    The affected item has been quarantined and returned to the manufacturer.

Device

Small Pedicle Probe ELL-IN 02 23-N
  • Model / Serial
    Small Pedicle Probe ELL-IN 02 23-NModel Reference Number: ELL-IN 02 23-NBatch Number: 3-8213ARTG Number: 228975
  • Manufacturer
    Spineart Australia Pty Ltd

Manufacturer

Spineart Australia Pty Ltd