Events

Retiro De Equipo (Recall) de MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or restoration of bony contour in craniofacial defects.)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-01367-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-16
  • 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-01367-1
  • 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
    Stryker has become aware that there is a higher occurrence rate of implant damaged during intra-operative handling for the part number noted above. additionally, a loss of adhesion between the barrier sheet and the porous sheet may be also experienced during intra-operative handling and modification. post-operative harm is unlikely to be associated or identified with the use of the affected device.
  • Acción
    Stryker is informing all the MEDPOR barrier users of the issue and recalling the device. A Stryker Representative will contact the customer to arrange for product return and replacement. This action has been closed-out on 18/07/2016.

Device

MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or re...
  • Modelo / Serial
    MEDPOR Barrier Sheets – Orbital Floor Implant 38mm X 50mm X 1.6mm(Intended for augmentation or restoration of bony contour in craniofacial defects.)Catalogue Number: 9305Lot Numbers: A1312011, 77004 & 81799ARTG Number: 187178
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA