Events

Retiro De Equipo (Recall) de PFNA Nails (used 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-01266-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-24
  • 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-01266-2
  • 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
    It was discovered that the above part and lot numbers may have the incorrect anodised colour. an implant with the incorrect anodised colour would not cause harm to the patient. if the user identifies the nonconformity during surgery, marginal surgical delay may occur while an alternate implant is located.
  • Acción
    JJM is advising users to inspect and quarantine affected stock for return to JJM. This action has been closed-out on 05/09/2016. This action has been closed-out on 05/09/2016.

Device

PFNA Nails (used during internal fixation surgery)
  • Modelo / Serial
    PFNA Nails (used during internal fixation surgery)PFNA ø10 125° L240 TAN Part Number: 472.260S, Lot Number: 7913867PFNA ø11 125° L240 TAN Part Number: 472.261S, Lot Number: 2812685PFNA ø10 long r 125° L340 TAN Part Number: 472.275S, Lot Number: 2806520ARTG Number: 161140
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes