Events

Retiro De Equipo (Recall) de MEDPOR Facial and Oculoplastic Sizer Sets and TLS Drain 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 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-2017-RN-00052-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-11
  • 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-2017-RN-00052-1
  • 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
    A report has been received indicating that the outer label of a medpor sizer set states ‘sterile’, whereas the product is actually delivered non-sterile. investigations have revealed that additional products and lots have an incorrect sterility status on their labels. the introduction of a non-sterile device into the sterile surgery field could potentially cause infection requiring additional medical or surgical treatment.
  • Acción
    Stryker is advising users to inspect their inventory and quarantine affected stock. They are requested to contact Stryker to coordinate the return of affected products for a resupply or a credit. This action has been closed out on 16 June 2017.

Device

MEDPOR Facial and Oculoplastic Sizer Sets and TLS Drain System
  • Modelo / Serial
    MEDPOR Facial and Oculoplastic Sizer Sets and TLS Drain SystemItem Numbers: 6630, 9951, 9952Multiple Lot NumbersARTG Numbers: 258033, 264273
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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