Events

Retiro De Equipo (Recall) de Device Recall Incise Zirconia Coping (CBZR0102)

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 Biomet 3i, 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
    58769
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2838-2011
  • Fecha de inicio del evento
    2010-12-01
  • Fecha de publicación del evento
    2011-07-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-07-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100493
  • 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
    Restoration, porcelain - Product Code NSP
  • Causa
    On december 1, 2010 biomet 3i recalled their product incise zirconia coping (cbzr0102). the coping contains a manufacturing defect. coping is oversized. all affected direct accounts were notified by letter on december 14, 2010.
  • Acción
    Biomet 3i sent an "MEDICAL DEVICE RECALL" letter dated December 14, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to complete and fax the Product Recall Response form to 561-514-6316. In addition, a shipping label is enclosed with the letter for returning the affected product. Customers with questions and concerns should contact Biomet 3i recall coordinator at 561-776-6906.

Device

Device Recall Incise Zirconia Coping (CBZR0102)
  • Modelo / Serial
    Lot numbers: 97646, 97415, 97418, 97422, 97417 97421, 97420, 97481, 97423, 97419, 97488, 97476, 97478, 97486 97490, 97416.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) and the country of Canada.
  • Descripción del producto
    "***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 800-342-5454 www.biomet3i.com Please consult instructions for use and recommendation***For Dental Lab use ONLY Non-sterile/For single Use***" || Indicated for use in restorative procedure to affix the final prosthesis to the abutment. Coping and frameworks provide the base structure for final porcelain application as the final step of creating a restoration. The devices are intended to be used to create final restoration for dental reconstruction with either a prepared tooth or dental implant abutment.
  • Manufacturer
    Biomet 3i, LLC

Manufacturer

Biomet 3i, LLC
  • Dirección del fabricante
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • 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