Retiro De Equipo (Recall) de Cemented resurfacing patellar implant, Ø 33mm and 36mm

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Amplitude 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-01013-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-15
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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 reported to amplitude that sealing of some pouches is not as resistant as intended and could compromise their integrity, resulting in non-sterile devices. this may increase the risk of post-operative infection and may lead to an increased surgical time to locate an alternative device.
  • Acción
    Amplitude is advising users to inspect stock and quarantine the affected batches for return. This action has been closed-out on 10/05/2017.

Device

  • Modelo / Serial
    Cemented resurfacing patellar implant, Ø 33mm and 36mmCemented resurfacing patellar implant - Ø 33mmReference Number: 1-0200833Batch Number: 236419Cemented resurfacing patellar implant - Ø 36mmReference Number: 1-0200836Batch Number: 236412ARTG Number: 216375
  • Manufacturer

Manufacturer