Events

Retiro De Equipo (Recall) de Device Recall Replace Select Tapered TiU NP

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 Nobel Biocare Usa Llc.

¿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
    70821
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1416-2015
  • Fecha de inicio del evento
    2015-03-09
  • Fecha de publicación del evento
    2015-04-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135203
  • 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
    A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
  • Acción
    Nobel Biocare sent an Important - Field Correction letter dated March 6, 2015, to all affected customers and another recall letter dated dated March 10, 2015, to all affected customers to inform them that Nobel Biocare Quality Management Systems observed an issue with a material used in the packaging of their implants. The firm's internal analysis has confirmed that this material is not according to their standards. The letters provide the problems identified and the actions to be taken. Customers were instructed to return the affected product(s) not yet used to Nobel Biocare to receive a replacement product. Customers were also instructed to complete the attached Acknowledgement form and fax it to 714-282-5073 or email it to aeinfo@nobelbiocare.com. Customers with questions were instructed to contact their customer service department. For questions regarding this recall call 714-282-4800.

Device

Device Recall Replace Select Tapered TiU NP
  • Modelo / Serial
    Batch No. 13012695.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Sweden, Turkey, and United Arab Emirates.
  • Descripción del producto
    Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. || Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
  • Manufacturer
    Nobel Biocare Usa Llc

Manufacturer

Nobel Biocare Usa Llc
  • Dirección del fabricante
    Nobel Biocare Usa Llc, 22715/22725 Savi Ranch Pkwy, Yorba Linda CA 92887
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA