Events

Retiro De Equipo (Recall) de Pull Reduction Device for Percustaneous Drill Guide 4.3mm (Supplied as part of the VA Distal Femur set)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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-2015-RN-00569-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-29
  • 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-2015-RN-00569-1
  • 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
    The affected parts and lots of the pull reduction devices may have been manufactured to an incorrect hardness specification whichcould result in intraoperative breakage.In the event of an intraoperative breakage a surgical delay could occur. breakage of the instrument into fragments during active use could lead to a significant prolongation of surgery time as the surgeon attempts to retrieve the pieces including use radiographic imaging to determine location and size of fragment.
  • Acción
    Johnson & Johnson Medical is requesting their customers to check their inventory to determine if they have any affected product. Affected stock must be quarantined in preparation for return to Johnson & Johnson Medical. This action has been closed-out on 05/12/2016.

Device

Pull Reduction Device for Percustaneous Drill Guide 4.3mm (Supplied as part of the VA Distal Femu...
  • Modelo / Serial
    Pull Reduction Device for Percustaneous Drill Guide 4.3mm (Supplied as part of the VA Distal Femur set)Part Number: 03.120.023Multiple lot numbers affectedARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes