Events

Retiro De Equipo (Recall) de Triathlon TS Tibial Augments Sizes 3 and 6

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia Pty Ltd.

¿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-2018-RN-00162-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-26
  • 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-2018-RN-00162-1
  • 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
    Stryker has discovered that the product/lot combinations referenced above may contain the incorrect size implant from what is labelled on the box.The triathlon ts tibial augments are laser marked with lot and catalogue number. although the product packaging for the four lots may not match the product contained within, the laser marked details on the implant would increase the likelihood that the surgeon or surgical staff would recognise that the incorrect implant was contained in the package.The size 3 and 6 triathlon ts tibial augments are also visibly different in size. the tibial augment implant can be compared to the corresponding size tibial augment trial (item number: 5545t301 and 5546t601) which would alert a user to a size mismatch.
  • Acción
    Stryker is advising users that patients implanted with the affected products should continue to be followed up as per the normal protocol established with their surgeons.

Device

Triathlon TS Tibial Augments Sizes 3 and 6
  • Modelo / Serial
    Triathlon TS Tibial Augments Sizes 3 and 6Item Number: 5545A3301, 5546A601Lot Numbers: ER9WA1AARTG Number: 242298(Stryker Australia Pty Ltd - Knee wedge)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA