Retiro De Equipo (Recall) de balanSys RP Tibial Plateau TiNbN cem

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Mathys Orthopaedics Pty Ltd.

¿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
    Mathys has received several reports about soft tissue reactions due to the wear of particles of unknown origin detected during a revision of surgereies of balansys rp tinbn total knee protheses in patients that are suffering persisting pain and synovitis. this debris can cause infections leading to soft tissue damage which may compromise the result of the total knee arthroplasty.Patients who experience symptoms including limited mobility, pain, swelling, etc. may need to contact their treating physician. the need for any additional follow-up, mri or ultrasound scans, arthroscopy or revision surgery should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances.
  • Acción
    This action has been closed-out on 09/08/2017.


  • Modelo / Serial
    balanSys RP Tibial Plateau TiNbN cemItem Numbers: 72.34.0155, 72.34.0156, 72.34.0157, 72.34.0158, 72.34.0159, 72.34.0160, 72.34.0161, 72.34.0162Reference Number: FSCA 17/03ARTG Number: 211086
  • Manufacturer