Events

Retiro De Equipo (Recall) de Device Recall Zimmer Dental Tapered ScrewVent T Implant

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
    68584
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2050-2014
  • Fecha de inicio del evento
    2014-06-25
  • Fecha de publicación del evento
    2014-07-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128266
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Causa
    Zimmer dental is conducting a voluntary recall of a single lot of the tapered screw-vent implant, catalog number tsvt6b13, lot number 62284006, due to a potential crack in the cap of the outer vial.
  • Acción
    Recall notification letters sent to customers on 06/25/14. The recall letter, titled "URGENT DEVICE RECALL NOTICE", delivered to customers via a courier, with instructions for returning any unused affected product. The recall letter was accompanied with a response form and provided the following information to customers: product information with codes, reason for recall, risks, responsibilities, MedWatch Reporting and contacting information.

Device

Device Recall Zimmer Dental Tapered ScrewVent T Implant
  • Modelo / Serial
    Catalog Number TSVT6B13, Lot Number 62284006. 5-year expiration. January 2018.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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