Retiro De Equipo (Recall) de Device Recall LOW PROFILE NONLOCK 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, 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
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component, metal composite - Product Code LXT
  • Causa
    A biomet investigation found that the low profile non-locking screw 2.7mmx22mm screw (part number: 131227222 lot: rm105e) was anodized green and should have been anodized gold per the print.
  • Acción
    On 3/18/2015, Biomet issued an URGENT MEDICAL DEVICE RECALL NOTICE to affected distributors and one medical facility. Notification included the reason for recall, description of affected product, statement of no expected patient health risk, and actions required of the addressee. Questions related to the recall notification should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.


  • Modelo / Serial
    REF 131227222 LOT RM105E
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution-including the states of CA, IA, NY, FL, PA, UT, NC, SC, KY, CO, MA, GA, WA, TX, OK, and IL.
  • Descripción del producto
    LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; || LOT RM105E. || Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
  • Manufacturer


  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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