Events

Retiro De Equipo (Recall) de Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as part of the Intramedullary Nail System)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew 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-00980-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-22
  • 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-00980-1
  • 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
    Smith & nephew pty ltd is advising several lots of trigen internal hex captured recon screw blue 6.4mm x 65mm were supplied with incorrect instructions for use (ifu). the fracture fixation ifu (reference 81078017) was packaged with the device instead of the correct intramedullary nail system ifu (reference 81090283). affected products do not need to be returned. the affected products meet all other product specifications and can be used.
  • Acción
    Smith & Nephew are providing users with the correct Instructions for Use (IFU). This action has been closed-out on 23/05/2017.

Device

Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as p...
  • Modelo / Serial
    Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as part of the Intramedullary Nail System)Model Number: 71642365Batch Numbers: 12BM01456, 12FM15060, 12JM09146, 13AM18101, 13EM08756, 13GM11807, 13GM11808, 13GM18304, 13GM20483, 13GM20486, 13HM20836, 15CM19083, 15FM02129ARTG Number: 104369
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd