Events

Retiro De Equipo (Recall) de TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125D

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 Surgical 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-2014-RN-00757-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-08
  • 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-2014-RN-00757-1
  • 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 manufacturer has identified a manufacturing error which results in the proximal lag screw being positioned incorrectly. in the event an incorrectly positioned proximal lag screw hole inhibits drilling and causes the user to hit the nail, the following issues could occur: the nail is removed and/or the procedure is delayed, the nail’s fatigue life is reduced, causing the nail to fail within a short period of time.
  • Acción
    The affected customer has been requested to inspect their inventory and quarantine the affected stock. The local Smith & Nephew Surgical representative will contact the customer to arrange for the product to be returned.

Device

TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125D
  • Modelo / Serial
    TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125DBatch Number: 14CM03676Model Number: 71675206ARTG Number: 104370
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd