Events

Recall of AMPLITUDE Orthopaedic Surgical Instruments

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Amplitude 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-01059-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01059-1
  • 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
    Amplitude identified an error regarding the automated cleaning process in the instructions for use (ref. no103 indices j, k and l) supplied with its surgical instruments since 2012. the protocol is not the correct one and does not correspond to the validated cycle, although it is applicable for the universal handle (ref. 2-0232100). the automated cleaning (washer - disinfector step) in the ifu incorrectly states to process in a solution of alkaline detergent (e.G. 5% mediclean) for 15 minutes at 40°c. the correct procedure is to process in a solution of alkaline detergent (e.G. 0.5% mediclean) for 10 minutes at 93°c.
  • Action
    A copy of the revised Instructions For Use NO103 – revision M is attached with the customer letter. Amplitude is asking the customers to verify the automated cleaning parameters in the revised instructions for all other Amplitude instruments (except the universal handle). This action has been closed-out on 18/03/2016.

Device

AMPLITUDE Orthopaedic Surgical Instruments

Manufacturer

Amplitude Australia Pty Ltd