Events

Retiro De Equipo (Recall) de Device Recall BIOMET MICROFIXATION Trauma One SYSTEM

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 Microfixation, Inc..

¿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
    52672
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1949-2009
  • Fecha de inicio del evento
    2009-02-16
  • Fecha de publicación del evento
    2009-09-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83611
  • 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
    Bur, dental - Product Code EJL
  • Causa
    Biomet microfixation is recalling the 46-1004, trauma one drill, 18.X115 mm, 26 mm stop lot numbers 619450 and jc1002. the drills may be color-banded blue instead of brown. the color is a visual aid in determining what system the drill goes with. the blue indicates the drill is for the 2.0mm system. the brown indicates the drill is to be used for our 2.3mm system. the drill is etched and labe.
  • Acción
    Biomet Microfixation, Inc. issued an Urgent Medical Device Recall Notice dated February 19, 2009 via certified mail with return receipt. The notice informed users of the affected device and instructed them to immediately discontinue use and return to the firm. Consignees were also instructed to complete and return an Inventory Reconciliation sheet via fax to 1-904-741-9425. For further information, contact Biomet Microfixation, Inc. at 1-800-874-7711 or 1-904-741-4400.

Device

Device Recall BIOMET MICROFIXATION Trauma One SYSTEM
  • Modelo / Serial
    Lot Numbers: 619450 and JC1002.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- Texas, Maryland, Florida, Washington DC, Michigan, Kansas Colorado and Missouri.
  • Descripción del producto
    BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP STAINLESS STEEL, NON-STERILE, BIOMET MICROFIXATION, INC. 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA.
  • Manufacturer
    Biomet Microfixation, Inc.

Manufacturer

Biomet Microfixation, Inc.
  • Dirección del fabricante
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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