Retiro De Equipo (Recall) de Biomet 3i Narrow Right Angle Large Driver Tip

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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
    dental and restorative instrument - Product Code NDP
  • Causa
    Rasq3n, a square, abutment screw driver tip has been labeled and distributed as rash3n, a hexed, abutment screw driver tip. additionally, the rasq3n received the rash3n's laser marking "rash3n" during manufacturing.
  • Acción
    Beginning on or about 08/10/2015 customers will be notified in writing via FEDEX and instructed to to check their inventory for the identified product and to return any unused quantiles along with the recall response. Biomet 3i will promptly issue replacement product.


  • Modelo / Serial
    Model # RASQ3N Lot # 1184554
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KY, LA, MA, MD, MI, MS, NC, NE, NJ, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and District of Columbia Argentina, Australia, Belgium, Canada, Colombia, Greece, Hong Kong, Ireland, Italy, South Korea, and Kuwait.
  • Descripción del producto
    Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.
  • Manufacturer


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