Events

Retiro De Equipo (Recall) de Device Recall Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit

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
    74782
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2375-2016
  • Fecha de inicio del evento
    2016-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148438
  • 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
    Drill, bone, powered - Product Code DZI
  • Causa
    Incorrect drill protocol in the instructions for use (ifu).
  • Acción
    The firm, Nobel Biocare, sent "IMPORTANT-QUALITY MESSAGE" Field Correction Letters and response forms dated July 22, 2016. The letter describes the product, problem and actions to be taken and informs the customers that the titles of the IFU and the Manual are "NobelGuide for NobelParallel Conical Connection" (ID number 2002) and "Guided Surgery with Nobel Parallel Conical Connection" (ID number 79423). The Customers are instructed to review if you have a printed version of the IFU or the Manual related to the article and discard them; and to complete the attached "Quality Message Acknowledgement" form and fax to 714-998-9348 or email to: joann.radovich@nobelbiocare.com. Customers are informed that an English version of the corrected IFU is attached to the letter and translated versions will be available on the Nobel Biocare website for electronic IFU's http://www.nobelbiocare.com/IFU within 30 days. If you have further questions, contact our customer service department at 714-322-5001.

Device

Device Recall Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit
  • Modelo / Serial
    Article 38072-all lots
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.
  • Descripción del producto
    Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit || Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. || The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.
  • 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