Events

Retiro De Equipo (Recall) de Angular Stable Locking System (ASLS), 5.0 mm, Resorbable (Used with Synthes cannulated titanium intramedullary nails)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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-2015-RN-00276-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-27
  • 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-2015-RN-00276-1
  • 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 label of affected product lists the incorrect sterilisation and expiration date. incorrect expiration date listed on label: 2018-06actual expiration date: 2017-07incorrect sterilisation date listed on label: 2014-06actual sterilisation date: 2013-10if the affected lot number were to be used past the expiration date of july 2017, malunion/non-union may occur.
  • Acción
    Johnson & Johnson Medical Pty Limited (JJM) is advising customers that they can return the affected stock if they choose to do so. This action has been closed-out on 02/06/2016.

Device

Angular Stable Locking System (ASLS), 5.0 mm, Resorbable (Used with Synthes cannulated titanium i...
  • Modelo / Serial
    Angular Stable Locking System (ASLS), 5.0 mm, Resorbable (Used with Synthes cannulated titanium intramedullary nails)Part Number: 08.025.044.01SLot Number: 8586243ARTG Number: 168395
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes