Events

Recall of METS Modular Tumour System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Corin 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-2017-RN-00214-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00214-1
  • 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
    There have been reports that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the mets modular tumour system's stem feature. in some instances, the implant assemblies have punctured through both inner and outer pouches, compromising the sterile barrier and causing internal damage to the device carton.
  • Action
    Stryker is advising surgeons to monitor patients through regular consultations to determine the need for any treatment.

Device

METS Modular Tumour System
  • Model / Serial
    METS Modular Tumour SystemItem Numbers: mkfh/SmSt, mkrhm/SmLg, mkrhm/StdSt, msfshft/135, msfshft/150, msiss/15x27C, msiss/O15x30x38C, msiss/O15x36x44C, msiss/O30x30x38CMultiple Batch NumbersARTG Numbers: 278135, 278137, 246516, 276028, 278138
  • Manufacturer
    Corin Australia Pty Ltd

Manufacturer

Corin Australia Pty Ltd