Events

Retiro De Equipo (Recall) de Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II and Reversed Fracture Instrument sets, YKAD83 &YKAD95;)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Tornier 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-2013-RN-01035-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-23
  • 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-2013-RN-01035-1
  • 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
    Following the identification of the disassociation of an impactor tip during a surgery, without any clinical consequences for the patient, tornier has initiated recall of all lots of aequalis reversed ii and reversed fracture impactors (items number mwd021, mwd023, mwd024, mwd025). upon review of the event, tornier determined that a redesign of the instrumentation was warranted.This recall action was carried out prior to approval by the therapeutic goods administration.
  • Acción
    In the interim the manufacturer (Tornier SAS) has recommended an alternative method using other impactors that are available in other Tornier shoulder instrument sets. Tornier has issued a specific operative technique to explain which impactor to be used. The replacement with new impactors has begun.

Device

Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II an...
  • Modelo / Serial
    Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II and Reversed Fracture Instrument sets, YKAD83 &YKAD95;)Aequalis Reversed II Insert Impaction HandleItem Number: MWD021Aequalis Reversed II Insert Impactor TipItem Number: MWD023Hemiprosthesis Adaptor Impactor TipItem Number: MWD024Aequalis Reversed II Anatomic Head Impactor TipItem Number: MWD024ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd