Events

Retiro De Equipo (Recall) de DePuy Synthes Attune Intuition Distal Femoral Jig

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por DePuy Ireland UC.

¿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
    17639
  • Fecha de inicio del evento
    2014-11-14
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • Causa
    This correction is being issued because if the metal pin bushing is overloaded, there is the potential for partial or full displacement of the metal pin bushing along with fracture of the plastic around the metal pin bushing. if the plastic around the metal pin bushing fractures, there is the potential for fragments of the fractured plastic to be left in the patient.
  • Acción
    Product to be exchanged

Device

DePuy Synthes Attune Intuition Distal Femoral Jig
  • Modelo / Serial
    Model: Part numbers: 254400521 and 254400520, Affected: All lots
  • Manufacturer
    DePuy Ireland UC

Manufacturer

DePuy Ireland UC