Events

Retiro De Equipo (Recall) de Synthes Sternal ZIPFIX Application Instrument

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
    19172
  • Fecha de inicio del evento
    2015-09-23
  • 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
    In the affected lots of the application instrument for sternal zipfix :, * the end cap may loosen, thus reducing the tension applied to the implant., * the end cap may detach, allowing the tensioning spring to also become detached, making the instrument non-functional., if the end cap is loose, the maximum tension applied to the implant is reduced and may lead to insufficient sternal bone reduction. if the tension coil spring detaches completely from the zipfix application instrument while closing the sternum, it is possible that the spring or nut could fall into the thoracic cavity and go undetected. if the nut/spring is retained in the thoracic cavity, adverse tissue reaction may occur. no such occurrence has been reported to date.
  • Acción
    Product to be returned to supplier

Device

Synthes Sternal ZIPFIX Application Instrument
  • Modelo / Serial
    Model: 03.501.080, Affected: Multiple lot numbers
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH