Events

Rappel de Kirschner Wire 1.6 mm, with drill tip, length 200 mm

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

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-2015-RN-01210-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-12-16
  • 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-2015-RN-01210-1
  • 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
    The kirschner wire is made from co35ni35cr20mo10 (mp35n) which is cobalt based alloy containing 35% nickel. however, the label and technique guide incorrectly indicate that the devices are made of stainless steel. the product is shipped with an insert which references the potential risk of allergy/hypersensitivity reactions, but there is no specific information on the label or in the technique guide with regards to the percentage of nickel content in the devices. although unlikely, there is a potential for surgeons to use the affected products on patients with a nickel allergy, which could lead to an allergic reaction. as mp35n is a more corrosion-resistant alloy and more biocompatible than stainless steel, the likelihood of a patient being exposed and sensitised to a higher amount of nickel or other alloys is low compared to a product manufactured from stainless steel.
  • Action
    The sponsor is advising users to review the instructions listed in the customer letter. Users are not requested to return the product.

Device

Kirschner Wire 1.6 mm, with drill tip, length 200 mm

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes