Events

Retiro De Equipo (Recall) de Aequalis Ascend Flex Shoulder System PTC Humeral Stems

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-2017-RN-00860-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-14
  • 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-00860-1
  • 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
    Wright medical has identified a deviation of the manufacturing method for one lot of aequalis ascend flex shoulder system ptc humeral stems. this is a documentary discrepancy with regulatory impacts, but for which the patient risk was assessed as negligible.The subcontractor (who have manufactured the affected parts), used in fact the manufacturing method validated for tornier sas internal manufacturing, whereas the justification for the authorisation to use this method by the subcontractor, was insufficiently documented.
  • Acción
    Measures to be taken by the customer: Wright Medical are asking that if any product is with customers, that they: 1. Locate and return parts; 2. Circulate this information to whom it may concern in the hospital; and 3. Inform a Tornier Representative of any adverse event.

Device

Aequalis Ascend Flex Shoulder System PTC Humeral Stems
  • Modelo / Serial
    Aequalis Ascend Flex Shoulder System PTC Humeral StemsReference Number: DWF602CLot Number: AA2028ARTG Number: 234030
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd