Events

Recall of LiNA Xcise Laparoscopic Morcellator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GRC 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-2015-RN-00119-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00119-1
  • 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
    Grc surgical pty ltd, following recent advice and review of the instructions for use (ifu) of this device by the therapeutic goods administration (tga), is issuing a product correction to replace the ifu previously supplied with his product. the previous ifu has been identified as not containing sufficient warnings to adequately ensure safe use of the device. changes to update the ifu have been reviewed by the tga, and are in response to a tga safety advisory statement following advice by the urogynaecological devices working group on 4th august 2014 regarding the use of laparoscopic power morcellators (https://www.Tga.Gov.Au/alert/laparoscopic-power-morcellators-update-4-august-2014) .
  • Action
    GRC Surgical Pty Ltd is requesting all the users to quarantine the devices until the existing IFU's are removed from circulation and replaced with the updated IFU. This action has been closed-out on 20/04/2017.

Device

LiNA Xcise Laparoscopic Morcellator
  • Model / Serial
    LiNA Xcise Laparoscopic MorcellatorReference No: MOR-1515, MOR-1515-1, MOR-1515-6 ARTG Numbers: 226906 & 180377
  • Manufacturer
    GRC Surgical Pty Ltd

Manufacturer

GRC Surgical Pty Ltd
  • Source
    DHTGA