Events

Retiro De Equipo (Recall) de PFN/PFNA Insertion Handle (used for the insertion of Proximal Femur Nail during internal fixation surgery)

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-01211-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-10
  • 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-01211-1
  • 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
    Johnson & johnson medical pty. ltd. (jjm) is issuing a recall for specific lots of versions 1, 3.1 & 3.2 of the pfn / pfna insertion handle. the pfn/pfna insertion handle is made to insert pfn / pfna / pfnaii / pfna augmented nails. the insertion handle may break when struck with a hammer during the nail insertion process.
  • Acción
    JJM is advising users to inspect stock quarantine affected units for return to JJM.

Device

PFN/PFNA Insertion Handle (used for the insertion of Proximal Femur Nail during internal fixation...
  • Modelo / Serial
    PFN/PFNA Insertion Handle (used for the insertion of Proximal Femur Nail during internal fixation surgery)Versions 1, 3.1 and 3.2Part Number: 357.012Multiple 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