Events

Recall of Scherbak Weights – 400 gr and 800 gr (used with Scherbak vaginal speculum)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medical & Optical Instruments 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-2014-RN-00944-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00944-1
  • 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
    Medical & optical has been advised by kls martin 400gr and 800gr weights, placed in the market place for the scherbak vaginal speculum, fractures can occur in the laser welded seam between the holding hook and the weight involved.
  • Action
    Medical & Optical is recalling the affected stock and a replacement of the affected weights will be provided free of charge. This action has been closed-out on 04/04/2017.

Device

Scherbak Weights – 400 gr and 800 gr (used with Scherbak vaginal speculum)
  • Model / Serial
    Scherbak Weights – 400 gr and 800 gr (used with Scherbak vaginal speculum)Affected part numbers: Scherbak Weight, 400gr - Art. No. 32-302-10-01Scherbak Weight, 800gr - Art. No. 32-302-12-01Full set: Art. No. 32-302-00-01ARTG number: 177280
  • Manufacturer
    Medical & Optical Instruments Australia Pty Ltd

Manufacturer

Medical & Optical Instruments Australia Pty Ltd