Events

Retiro De Equipo (Recall) de Synthes Cortex Screw

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
    20109
  • Fecha de inicio del evento
    2016-05-02
  • 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
    Specific part and lot of the 4.5mm cortex screws, length 20mm may contain a 4.5mm cortex screw that s 22mm in length. the screws are both etched and labelled with the 20mm part numbers., the outside package labelling and the etching on the product would indicate to the user that the screw is 2mm shorter than its actual length of 22mm., the potential harm of damage to surrounding structures ,including damage to articular surface during insertion, could occur depending upon the location and angle of screw.
  • Acción
    Product to be returned to supplier

Device

Synthes Cortex Screw
  • Modelo / Serial
    Model: 414.82, Affected: 2610310
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH