Retiro De Equipo (Recall) de Slotted Femoral Head Provisional

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 Zimmer, 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
    Template - Product Code HWT
  • Causa
    Complaints have been received reporting sub-optimal fit between provisional femoral heads (versys and mis) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp.
  • Acción
    Zimmer, Inc. sent an E-mail letter dated April 21, 2011, to all affected customers in the US. A June 2011 E-mail was sent to all customers outside the US. The letters requested Inventory & Operations Managers to check product for proper fit /function, complete the return form with worn provisional heads to Zimmer Inc, Attention Product Service, 1777 West Center St. Warsaw, IN 46580. For questions regarding this recall call 574-372-4753.


  • Modelo / Serial
    All lots including lot 78939000 (1/7/2002) to present
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
  • Descripción del producto
    00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 || 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 || 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 || 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 || 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 || The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
  • Manufacturer


  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source