Events

Retiro De Equipo (Recall) de Synthes SynFix-LR Implant Holder

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
    16641
  • Fecha de inicio del evento
    2014-05-06
  • 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: Synthes New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, Auckland 1060
  • Causa
    Complaints have been received which describe the synfix-lr implant holder breaking at the interface between the implant and holder. if an un-retrieved device fragment remains threaded into the plate, it will not be possible to properly attach the synfix-lr aiming device to the implant (plate). proper attachment of the aiming device to the plate is required for accurate insertion of the four synfix-lr screws into the synfix-lr implant (plate) and vertebral bodies. if the tip of the holder should break, the potential exists for an un-retrieved device fragment (urdf) to be left in the synfix-lr implant.
  • Acción
    Instructions for use to be updated

Device

Synthes SynFix-LR Implant Holder
  • Modelo / Serial
    Model: Part Number 03.802.039, Affected: All lots
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH