Events

Retiro De Equipo (Recall) de Device Recall TaperedScrew Vent 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
    68862
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2144-2014
  • Fecha de inicio del evento
    2014-07-17
  • Fecha de publicación del evento
    2014-08-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128883
  • 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 recalling the tapered screw-vent implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm.".
  • Acción
    A recall letter dated 7/22/14 was sent to all customers who purchased the Tapered Screw-Vent Implant to inform them of the recall by Zimmer Dental. The letter informs the customers of the problems identified, risks involved, and the actions to be taken. Customers with questions are instructed to contact Zimmer Dental Customer Service at (800) 854-7019, 7-5pm, Mon-Fri. Customers are instructed to complete the customer response form and e-mail a copy to corporatequality.postmarket@zimmer.com or fax to (574) 372-4265.

Device

Device Recall TaperedScrew Vent Implant
  • Modelo / Serial
    Lot No. 62552804
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Holland, Italy, and Japan.
  • Descripción del producto
    Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
  • 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