Events

Retiro De Equipo (Recall) de Spectra System/Legacy Guided Surgery Handle Kit Inserts

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Implant Direct Oceania 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-01423-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-11-20
  • 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-01423-1
  • 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
    Implant direct oceania pty ltd is informing users of a recall of four (4) lots of spectra system/legacy guided surgery handle kit/inserts due to receiving 3 complaints on these products. through the reporting process, implant direct have found that the g-hk guided surgery handle inserts may be out of implant direct specification. the 3.4mm guide insert will not allow the 3.4 drill to pass through, since the diameter is too small. in addition, the 2.3mm guide may be too large for the drill. these discrepancies may lead to the possibility of a delay in procedure for the patient if the drilling sequence is discontinued or the clinician would need to continue the surgical procedure without the use of the drill guide. there have been no injuries as a result of this issue.
  • Acción
    Implant Direct is advising users to inspect stock and return affected units.

Device

Spectra System/Legacy Guided Surgery Handle Kit Inserts
  • Modelo / Serial
    Spectra System/Legacy Guided Surgery Handle Kit InsertsPart Numbers: G-HKKit Lot Numbers: 42562, 52987, 64245 and 74772ARTG Number: 296286
  • Manufacturer
    Implant Direct Oceania Pty Ltd

Manufacturer

Implant Direct Oceania Pty Ltd
  • Source
    DHTGA