Events

Retiro De Equipo (Recall) de Expert Tibial Nail PROtect Ø 8.0 – 13.0 mm, cannulated, length 255 – 465 mm, Gentamicin Sulphate, Titanium Alloy (TAN), dark blue, sterile, (Antibiotic coated tibial nail)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Synthes 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-2012-RN-01023-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-05
  • 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-2012-RN-01023-1
  • 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
    Synthes australia has identified an inconsistency found in the instructions for use supplied with the expert tibial nail protect. although no adversepatient events have been reported due to the identified issue, there is a potential that the use of the expert tibial nail protect in indications other than the ones in the technique guide of the expert tibial nail protect (036.000.380), may lead to improper application of this device and pose a health risk for patients.
  • Acción
    Customers to return any product held. Sponsor will advise customers once revised Surgical Techniques and Indications for Use are available.

Device

Expert Tibial Nail PROtect Ø 8.0 – 13.0 mm, cannulated, length 255 – 465 mm, Gentamicin Sulphate,...
  • Modelo / Serial
    Expert Tibial Nail PROtect Ø 8.0 – 13.0 mm, cannulated, length 255 – 465 mm, Gentamicin Sulphate, Titanium Alloy (TAN), dark blue, sterile, (Antibiotic coated tibial nail)Part number: 04.004.XXXSABAll lot numbers are affectedSupplied under the Special Access Scheme (SAS)
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd