Retiro De Equipo (Recall) de Generation 1 Jasper Vektor

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por TP (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-2018-RN-00482-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-05-17
  • 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
    Tp orthodontics has been made aware of incidents of device breakage as a result of stress overload. to date, no reports of serious injury have been received as a result of this issue.
  • Acción
    TP Australia is requesting customers: 1. Locate any of the affected lots identified in the table given in the customer letter and quarantine those products; and 2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or for a suitable refund, following the instructions given in the Customer Letter.

Device

  • Modelo / Serial
    Generation 1 Jasper VektorMultiple Catalogue and Lot NumbersARTG Number: 123576TP (Australia) - Orthodontic appliance, attachment
  • Manufacturer

Manufacturer