Retiro De Equipo (Recall) de Device Recall Synthes Minimally Invasive Reduction Screw System (MIRS)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Synthes USA HQ, Inc..

¿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 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Causa
    Synthes is initiating a medical device labeling correction following a detailed review of the current labeling in response to reported complaints. synthes has identified technique measures and has updated the labeling associated with this system. the labeling reflects updated technique recommendations and emphasizes the importance of avoiding rod mis-alignment.
  • Acción
    SYNTHES sent an Urgent Medical Device Labeling Correction letter dated June 18, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to replace the previous version of the labeling with the new labeling provided. In addition, they can access an electronic version of the labeling by accessing Product Literature at the following link: The new version can be identified by code J11031-B located at the bottom right corner of the back cover. To confirm their receipt and understanding of the information contained in the letter, the recall package also included a response form to be completed by consignee and returned to Fax: 610-251-9005 or Scan/email: Customers with questions were asked to call 1-800-620-7025, ext 5403 or contact their Synthes Spine Sales Consultant. For questions regarding this recall call 610-719-5377. The firm initiated this recall action on June 18, 2012 by sending an Urgent Medical Device Labeling Correction letter to all accounts. The updated labeling was Included with the notification letter.


  • Modelo / Serial
    Minimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA.
  • Descripción del producto
    MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. || The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
  • Manufacturer


  • Dirección del fabricante
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Empresa matriz del fabricante (2017)
  • Source