Retiro De Equipo (Recall) de Device Recall Coupler System II

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 Mizuho Orthopedic Systems 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
    Accessories, operating-room, table (kit) - Product Code FWZ
  • Causa
    Mizuho determined that current labeling of the coupler ii system required revisions after investigation of a complaint.
  • Acción
    Mizuhosi OSI sent an Urgent Medical Device Recall Communication letter dated February 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Mizuho OSI provided their customers of the affected product an updated Owner's manual. Customers were instructed to ensure they remove their existing Owner's Manual from use and repalce with the current Owner's Manual. If customers were unsure of the device's use, they should refer to the included Owner's Manual and ensure all users are properly trained, able to assess the device's status prior to and after each use. If customers were unsure of the status of their device, or of its use, they should call 1-800-777-4674 or outside of the USA 00+1=510-476-8199. Customers were asked to respond that the recall has been received, read, understood and communicated to those affected by this activity. A response should be sent via e-mail to For any questions regarding this recall call 1-800-777-4674 or outside of the USA 00+1=510-476-8199. was sent out on February 27, 2012 to all affected sites. This was after the original was sent to CDRH for review on January 31, 2012, but approval of revisions was not received until 2/27/12.


  • Modelo / Serial
    Model 5873
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Japan, South Korea, Lebanon, Malaysia, Netherlands, New Zealand, South Arabia, Singapore, Germany, South Africa, Spain, Sweden, UA. E., United Kingdom, and Australia.
  • Descripción del producto
    Coupler System II || Mizuho Orthopedic Systems, Inc. || Union City, CA 94587 || The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jackson Spinal Table Top). The Coupler II mounts onto the Spinal Surgery Top by using the Spinal Top Adaptor Brackets. The 5873 Coupler II is used to allow positioning of a patient on the table utilizing either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences, referred to as a Mayfield¿ clamp or the radiolucent or aluminum skull clamp referred to as the DORO¿ which is manufactured by pro med instruments Inc.
  • Manufacturer


  • Dirección del fabricante
    Mizuho Orthopedic Systems Inc, 30031 Ahern Ave, Union City CA 94587
  • Empresa matriz del fabricante (2017)
  • Source