Events

Retiro De Equipo (Recall) de Signature Ceramic Femoral Head

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Signature Orthopaedics 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-00091-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-05
  • 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-2018-RN-00091-1
  • 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
    Signature orthopaedics has been made aware that a 28 (s) femoral head was found labelled as a 32 (s) ceramic femoral head. investigation of production records confirmed that these batches may be mislabelled, with the packaged component's size not corresponding to the label.
  • Acción
    Signature Orthopaedics is advising users to quarantine all stock of the affected lot numbers and return to the sponsor.

Device

Signature Ceramic Femoral Head
  • Modelo / Serial
    Signature Ceramic Femoral HeadCatalogue Number: 111-152-624Batch Numbers: 78560, 78528Manufacture Date: 31/10/2017Expiry Date: 31/10/2022ARTG Number: 272595
  • Manufacturer
    Signature Orthopaedics Pty Ltd

Manufacturer

Signature Orthopaedics Pty Ltd