Retiro De Equipo (Recall) de Device Recall HT XDRIVE SCREW

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
    50113
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0282-2009
  • Fecha de inicio del evento
    2008-07-11
  • Fecha de publicación del evento
    2008-11-04
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2009-09-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Screw - Product Code JEY
  • Causa
    The packaging for the 91-2416, 2.4x16mm ht x-drive screw, lot 493200 actually contained the 99-6577, 2.0x7mm fossa x-drive screw.
  • Acción
    An "Urgent Medical Device Recall Notice" was sent to customers on 07/11/2008 by certified letter. The letter described the problem, the risk and asked that customers discontinue use of the product and return them to Biomet. Also, customers were provided with a Inventory Reconciliation sheet and asked to fax it back to Biomet. Please contact Biomet Microfixation at 1-800-874-771 or 904-741-4400, ext. 448 for assistance.

Device

  • Modelo / Serial
    Lot 493200
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • Empresa matriz del fabricante (2017)
  • 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