Events

Retiro De Equipo (Recall) de DePuy Synthes Pedicle Awls, technique guides & outer labels

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 Synthes GmbH.

¿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
    19222
  • Fecha de inicio del evento
    2015-10-09
  • 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
    The echnique guides for the systems mentioned above describe the pedicle awls as 4.0mm for use with screws (4.0mm - 7.0mm). these awls should be used with 5.0mm - 7.0mm screws. action is being taken to communicate changes being made to technique guides and outer labels in order to clarify the intended use of these two awls within these systems. there has been no change to the design or manufacture of the pedicle awls.
  • Acción
    Instructions for use to be updated

Device

DePuy Synthes Pedicle Awls, technique guides & outer labels
  • Modelo / Serial
    Model: 036.000.216, 036.001.185, 388.550, 388.656, Affected: All
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH