Events

Rappel de Tension Band Pins (Internal fixation pins)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medical & Optical Instruments 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-00449-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2014-05-09
  • 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-00449-1
  • 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
    Specific lots of tension band pins manufactured between july 2009 and march 2011 are being recalled because they were manufactured with astm f138 stainless steel but should have been manufactured with astm a276 stainless steel. both standards are grade 316l stainless steel and contain the exact same chemical elements but in different concentrations. although the biocompatibility was only tested on astm f138 there is no evidence to indicate that astm a276 is not biocompatible.
  • Action
    Medical + Optical is contacting their customers to arrange for the return of affected devices.

Device

Tension Band Pins (Internal fixation pins)
  • Modèle / numéro de série
    Tension Band Pins (Internal fixation pins)Part Numbers:TB-1550K-SLot Number: 223007TB-1570K-SLot Numbers: 220788, 230952 & 233742TB-1590K-SLot Numbers: 218700, 221465 & 223009ARTG Number: 99821
  • Manufacturer
    Medical & Optical Instruments Australia Pty Ltd

Manufacturer

Medical & Optical Instruments Australia Pty Ltd