Events

Recall of SwishTapered Implant 4.1mmD x12mmL SBM Dual Blast; 4.8mmD Platform

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Implant Direct Oceania 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-00064-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00064-1
  • 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
    Implant direct, through their regulatory affairs reporting process, have found that the extender that is packaged with the swishtapered implant have been packaged in the incorrect position (upside down in the plastic retainer). this discrepancy may lead to the possibility of the extender not seating properly in the implant.No reports of injury have been received to date.
  • Action
    Implant Direct is advising users to return any affected product.

Device

SwishTapered Implant 4.1mmD x12mmL SBM Dual Blast; 4.8mmD Platform
  • Model / Serial
    SwishTapered Implant 4.1mmD x12mmL SBM Dual Blast; 4.8mmD PlatformPart Numbers: 934112Kit/Refill/Syringe Lot Number: 69101Expiry date: 1 October 2020ARTG Number: 238870
  • Manufacturer
    Implant Direct Oceania Pty Ltd

Manufacturer

Implant Direct Oceania Pty Ltd
  • Source
    DHTGA