Events

Retiro De Equipo (Recall) de Device Recall Tapered ScrewVent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform

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 Dental 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
    67207
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0847-2014
  • Fecha de inicio del evento
    2014-01-06
  • Fecha de publicación del evento
    2014-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-07-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124976
  • 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 tsvwb11, lot 62470008, because some of the packages of this lot may have the cap label state ¿3.7 x 10mm instead of ¿4.7 x 11.5mm.
  • Acción
    Zimmer Dental initiated the recall on 01/06/2013 by sending out recall notifications via FedEx to domestic customers and via electric mail to international customers. Customers are sent a letter identifying the issue, product description with codes, risk, instructions, and contact information. The letter's instructions include locating the affected product and return unused product to Zimmer Dental and notifying the amount of product that has been consumed.

Device

Device Recall Tapered ScrewVent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform
  • Modelo / Serial
    Catalog Number TSVWB11, Lot 62470008.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE.
  • Descripción del producto
    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. || Class II, 510(k) K13227.
  • Manufacturer
    Zimmer Dental Inc

Manufacturer

Zimmer Dental Inc
  • Dirección del fabricante
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • 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