Events

Retiro De Equipo (Recall) de Device Recall Prosthesis Shoulder Hemi Humeral Metallic Uncemented. ExploR, ExploR Radial Head

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 Biomet, 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
    78705
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0269-2018
  • Fecha de inicio del evento
    2017-06-16
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160165
  • 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, elbow, hemi-, radial, polymer - Product Code KWI
  • Causa
    Zimmer biomet is conducting a medical device recall for the explor 6x24mm implantable stem with screw due to a complaint alleging that the modular radial hd lock screw was not included in the package for the stem.
  • Acción
    Zimmer Biomet sent US Fiedl action notices 6/16/17 via email and fed Ex. On 9/5/17, firm expanded their recall to include 1 lot and distributed Amended notices via email and FedEx

Device

Device Recall Prosthesis Shoulder Hemi Humeral Metallic Uncemented. ExploR, ExploR Radial Head
  • Modelo / Serial
    Part Lot UDI Number 11-210061 243610 and 202900; (01)00880304210448(17)260817(10)243610
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US, Canada, OUS.
  • Descripción del producto
    ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. || The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom of the tray for protection. The inner tray and the contents within will then have a Tyvek¿ lid heat sealed to the tray. The sealed inner tray will be fit into an outer PETG tray and a Tyvek¿ lid heat sealed to the tray. The entire sealed unit is placed in a SBS carton that will be shrink wrapped for protection.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Dirección del fabricante
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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