Events

Retiro De Equipo (Recall) de ENDOBON XENOGRAFT GRANULES 0.5 ML

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
    67194
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1233-2014
  • Fecha de inicio del evento
    2013-10-03
  • Fecha de publicación del evento
    2014-03-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124921
  • 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
    Bone grafting material, synthetic - Product Code LYC
  • Causa
    Individual pieces of a batch of biomet's endobon xenograft granules 0.5 ml (bovine bone substitute) may have an incorrect label with the wrong batch number.
  • Acción
    Biomet 3i sent a Medical Advisory Notice dated October 3, 2013 via mail, facsimile or telephone to all affected customers. The notice identified the product, the problem, and the action to be taken by the customers. The customers were instructed to do the following: 1) Review their inventor for any incorrectly labeled products and return them to their local Biomet distributor. 2) Provide this information to persons in their organization that uses or order these products. 3) Ensure that a copy of this letter is provided to any other organization to which the products maybe have been transferred. Customer were also instructed to respond to the attached Response Form via fax at 561-514-6316 or email to: domesticcomplaints@biomet.com. For any questions or concerns, call Biomet 3i Customer Service at 1-800-342-5454. For questions regarding this recall call 561-776-6706.

Device

ENDOBON XENOGRAFT GRANULES 0.5 ML
  • Modelo / Serial
    Model # ROX05, Batch # S0171051
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including CA, DC, FL, LA, MA, MO, NC, NJ, NY, TX, VA, WA and Hawaii and Internatially to Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Great Britain (UK), Ireland, Mexico, Poland, Portugal, and Singapore.
  • Descripción del producto
    ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) || Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.
  • 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