Events

Retiro De Equipo (Recall) de Kirschner Wire 1.6 mm, with drill tip, length 200 mm

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-01210-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-12-16
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01210-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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