Events

Retiro De Equipo (Recall) de Depuy Synthes Trauma RIA (Reamer/Irrigator/Aspirator) 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 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-2014-RN-01319-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-16
  • 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-01319-1
  • 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 expiration date on the label is incorrect. the affected sterile product components (comprising of a locking clip and a drive shaft seal packaged as separate parts) were labelled with expiration dates of 10 years rather than 2 years from the date of manufacturer.
  • Acción
    Synthes is advising their customers to check inventory and to quarantine and return any affected units. This action has been closed-out on 07/07/2016.

Device

Depuy Synthes Trauma RIA (Reamer/Irrigator/Aspirator) system
  • Modelo / Serial
    Depuy Synthes Trauma RIA (Reamer/Irrigator/Aspirator) system Part Numbers: 352.260S and 351.718.02S Multiple lot numbers affected ARTG Number:157016
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd