Events

Rappel de DHS/DCS Screw, sterile (Orthopaedic bone screw, non bio-degradable) DHS/DCS Screw 12.5mm, octagonal coupling, stainless steel, sterile, various length

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Synthes 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-2013-RN-00324-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-12
  • 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-2013-RN-00324-1
  • 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
    Synthes has two couplings in place for the dhs/dcs screws, standard with teethed recess and octagonal recess. the pictogram on the labels of the articles shows the wrong coupling. all other information on the label (e.G. coupling description in words) is correct.
  • Action
    Depuy Synthes is recalling the affected lots and is replacing them with unaffected units.

Device

DHS/DCS Screw, sterile (Orthopaedic bone screw, non bio-degradable) DHS/DCS Screw 12.5mm, octagon...
  • Modèle / numéro de série
    DHS/DCS Screw, sterile (Orthopaedic bone screw, non bio-degradable)DHS/DCS Screw 12.5mm, octagonal coupling, stainless steel, sterile, various lengthPart number: 280.XXXSDHS/DCS Screw, Titanium Alloy (TAN), sterile, various lengthPart number: 480.XXXS Multiple lot numbers affected.ARTG number: 157068
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd