Events

Retiro De Equipo (Recall) de Guide Wires and K-Wires for T2 and Gamma Nailing Systems

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-2016-RN-00002-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-04
  • 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-2016-RN-00002-2
  • 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
    It has been discovered that the seal integrity of the pouch may be decreased. a potential capillary defect in the sealing could potentially lead to the product becoming unsterile, which could result in an infection. no injury or harm has been reported for this event so far.
  • Acción
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.

Device

Guide Wires and K-Wires for T2 and Gamma Nailing Systems
  • Modelo / Serial
    Guide Wires and K-Wires for T2 and Gamma Nailing SystemsCatalogue numbers: 01520218S,12106450,18060050S,18060080S,18060083S,18060084S, 18060085S, 18060090S, 18060093S, 18061250S, 18061417S, 18063030S, 18063031SMultiple Lot Numbers affectedARTG Number: 190236
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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