Events

Retiro De Equipo (Recall) de Persona Personalized Knee System

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
    Recall
  • ID del evento
    63125
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2493-2012
  • Fecha de inicio del evento
    2012-09-07
  • Fecha de publicación del evento
    2012-09-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112646
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    Zimmer is initiating a recall of the cemented tibial drill for the zimmer persona personalized knee system due to three reports being received as of august 29. 2012 for tibial cortex perforation during preparation of the tibial bone. the investigation into the reports that have been received found that the perforations are occurring while using the cemented tibial drill. the perforations have o.
  • Acción
    Zimmer sent an Urgent Medical Device Recall dated August 2012 to distributors via electronic mail and Hospital risk managers and surgeons had notifications hand delivered by sales representatives. The recall notice describes the reason for the recall, emphasizes surgical technique to be used, includes instructions for delivering notifications to surgeons and risk managers, instructions for replacing the affected product, and instructions for returning the affected product. Customers were instructed to locate the affected product and contact their sales representative for replacement. Consignees are asked to fill out the Certificate of Delivery, scan it and send back per the instruction provided.

Device

Persona Personalized Knee System
  • Modelo / Serial
    Part 42-5399-018-00, Lots 62034571, 62089766
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide including the states of: AZ, CA, CO,FL, MN, IL, NJ, NY, OH, OR and the countries of Austrailia, Utd. Arab Emir., France, Germany, India, and Italy.
  • Descripción del producto
    Cemented Tibial Drill || Product Usage: || The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert the drill into the tibial bone.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • 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
    USFDA