Events

Retiro De Equipo (Recall) de Device Recall EP HEALING ABUTMENT

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
    58768
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2799-2011
  • Fecha de inicio del evento
    2010-02-23
  • Fecha de publicación del evento
    2011-07-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100612
  • 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, base metal - Product Code NSQ
  • Causa
    Biomet 3i of palm beach gardens, fl is recalling their certain ep healing abutment (iwth56). the healing abutment dimensions did not match outside label and laser etching on part. the product was actually 8mm but the package indicated 6mm.
  • Acción
    The firm, BIOMET 3i, initially contacted each US customer by telephone using a prepared phone script. Following telephone contact, the firm followed up each call with a faxed "Urgent: Medical Device Recall" letter dated March 1, 2010. International customers were notified first by email then by fax. The letter and email described the product, problem and actions to be taken. The customers were instructed to return the healing abutment(s) for replacement if they have not already opened and used the product; respond with the attached response fax and return the product(s) to the: Regulatory Affairs Department, BIOMET 3i, 4555 Riverside Drive, Palm Beach Gardens, FL 33410, Incident No. IC95863. BIOMET will send a replacement healing abutment(s) once the returned product is received. If you have any questions or concerns, please contact the Recall Coordinator at 561-776-6906.

Device

Device Recall EP HEALING ABUTMENT
  • Modelo / Serial
    Lot number: 6022691.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Australia, Europe and Japan.
  • Descripción del producto
    "***REF IWTH56***Certain EP HEALING ABUTMENT 5mm(D) X 5mm(P) X 6mm(H).*** Healing abutment*** STERILE.***Rx Only.*** Made in USA*** Implant Innovations, Inc. Global Headquarters 4555 Riverside Drive, Palm Beach Gardens, FL 33410 USA Tel: (800) 342-5454 www.3i.online.com. Outside US 561-776-6700***Implant Innovations Siberica S.L., WTC Almeda Park, Ed. 1 Planta 1a Pl. De la Pau s/n 08940-Cornella de Llobregat (Barcelona) Spain. Phone: +34 934 705500. Fax +34 933 717 849. Lot Number: 602691.***" || Biomet 3i healing abutments are temporary healing abutments for use in maintaining the soft tissue opening throughout the healing process of dental restoration.
  • 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