Events

Retiro De Equipo (Recall) de Beater-Positioner-Aligner(Multipurpose Impactor Handle - Orthopaedic implant inserter/extractor)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Lima Orthopaedics 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-01331-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-17
  • 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-01331-1
  • 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 lima orthopaedics investigation detected substandard welding performed by the supplier on the beater-positioner-aligner. specifically, the absence of base material pre-fusion and under-dimensioned welding radius was identified. there is a risk of injury to the surgeon or the patient, in case the flange of the instrument breaks and detaches with high speed from the body of the instrument.
  • Acción
    Lima is advising users to quarantine affected stock from use. Lima Orthopaedics will replacing the affected stock in the consignment sets.

Device

Beater-Positioner-Aligner(Multipurpose Impactor Handle - Orthopaedic implant inserter/extractor)
  • Modelo / Serial
    Beater-Positioner-Aligner(Multipurpose Impactor Handle - Orthopaedic implant inserter/extractor)Product Code: 9057.20.555Lot Numbers: 15AG0V0 and 16AG02JARTG Number: 176877
  • Manufacturer
    Lima Orthopaedics Australia Pty Ltd

Manufacturer

Lima Orthopaedics Australia Pty Ltd