Events

Rappel de AMPLITUDE Orthopaedic Surgical Instruments

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Amplitude Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-01059-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-10-03
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01059-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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