Retiro De Equipo (Recall) de Prodisc-C Vivo Cervical Disc Prosthesis (part of the Prodisc-C Vivo Cervical Disc Prosthesis System) Prodisc-C Vivo, uncemented convex, LD, 17x16mm, H5mm

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Prodisc-c vivo implants are packaged sterile in a double barrier setup, with an outer foil package and an inner blister package. for the impacted lot, the tyvek lid may be missing from the inner blister package. manufacturer’s assessment has identified that due to the double barrier sterile packaging, the sterility of the implants will continue to be maintained when the tyvek lid is missing. the packaging non-conformance has the potential to result in intraoperative surgical delay. when the outer foil pouch package is opened, the implant may dislodge from the uncovered blister package and has the potential to fall outside of the sterile field.
  • Acción
    Users are advised to inspect stock and quarantine any remaining product for return to Johnson and Johnson. Patients who are implanted with the affected stock should be monitored in accordance with standard practice for the Prodisc-C Vivo treatment process.


  • Modelo / Serial
    Prodisc-C Vivo Cervical Disc Prosthesis (part of the Prodisc-C Vivo Cervical Disc Prosthesis System)Prodisc-C Vivo, uncemented convex, LD, 17x16mm, H5mmPart Number: 04.670.955SLot Number: 9736836ARTG Number: 133399
  • Manufacturer