Events

Retiro De Equipo (Recall) de Coated Implant_Delta Extend

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 France SA.

¿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
    22011
  • Fecha de inicio del evento
    2017-09-21
  • 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 manufacturer has determined that lots produced in a specific machine were manufactured in a manner in which the post's diameter is out-of-specification. further investigation determined that the issue is related to the circularity of the cylinder. the circularity issue may cause the epiphysis to interfere with the stem and the two implants (epiphysis and stem) cannot be assembled.
  • Acción
    Product to be returned to supplier

Device

Coated Implant_Delta Extend
  • Modelo / Serial
    Model: , Affected: Modular Centered Epiphysis Size 1 HA, Modular Eccentric Epiphysis Size 1 Left HA, Modular Eccentric Epiphysis Size 1 Right HA, Modular Centered Epiphysis Size 2 HA, Modular Eccentric Epiphysis Size 2 Left HA, Modular Eccentric Epiphysis Size 2 Right HA
  • Manufacturer
    DePuy France SA

Manufacturer

DePuy France SA