Events

Retiro De Equipo (Recall) de Device Recall Multipolar

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
    63122
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0410-2013
  • Fecha de inicio del evento
    2012-08-31
  • Fecha de publicación del evento
    2012-11-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112642
  • 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, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
  • Causa
    Zimmer inc. is initiating a removal of the multipolar¿ bipolar cup liner 22 mm j.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled.
  • Acción
    Zimmer sent an Urgent Medical Device Recall letter to all affected consignees during the week of September 3, 2012. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, quarantine the recalled product and return remaining inventory. Customers were advised to complete Inventory Return Certification form attached.

Device

Device Recall Multipolar
  • Modelo / Serial
    Item 00-5001-040- 22; Lot 61261192, 61261194, 61296091.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA nationwide including the states of: AK, CA, IL, FL, HI, MI, MO, NC, NJ, NY, OH, PA, TX and the countries of Germany, Brazil, Canada, Japan, Taiwan, Thailand, India and Korea.
  • Descripción del producto
    Multipolar¿ Bipolar Cup Liner 22 mm LD.; || Item 00-5001-040-22 || Product Usage: || The liner snaps into the Multipolar¿ Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a popping sound as conformation that the femoral head has completed seated, as noted in surgical technique 97-5003-003-00
  • 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