Events

Rappel de Distraction Screws Packaged sterile(Orthopaedic bone screw)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par CareFusion Australia 316 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-2016-RN-01575-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-05
  • 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-2016-RN-01575-1
  • 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
    Between 1 july 2011 and 30 june 2016, the manufacturer has received 14 reports from customers in the usa of corrosion being evident on screws as they are removed from the immediate packaging. in australia, no reports of this issue have been received by bd. while no cases have been reported, degradation products of metal corrosion can result in inflammatory response locally and/or systemically. the elderly, pregnant, critically ill and immune-compromised patients may, however, be at greater risk if failure were to occur.
  • Action
    Customers are advised to immediately quarantine any remaining stock. They will be contacted to arrange return of the quarantined stock.

Device

Distraction Screws Packaged sterile(Orthopaedic bone screw)
  • Modèle / numéro de série
    Distraction Screws Packaged sterile(Orthopaedic bone screw)Models: S-0088, S-0089, S-0090 & S-0091All lot numbers that are still within their labelled 5 shelf life ARTG Number: 263050
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd