Events

Retiro De Equipo (Recall) de Device Recall Biomet Integral Centralizer Hip 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, 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
    72521
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0650-2016
  • Fecha de inicio del evento
    2015-11-17
  • Fecha de publicación del evento
    2016-01-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141358
  • 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
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Causa
    Pmma is listed as a material on the label but the product does not contain pmma.
  • Acción
    On 11/17/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Device

Device Recall Biomet Integral Centralizer Hip System
  • Modelo / Serial
    Part #11-162709  9mm Lots: 329750, 404380, 487400, 767120, 951680 Part # 11-162711 11mm Lots: 329760, 505030, 505050 Part # 11-162713 13mm Lots: 837750, 977460 Part # 11-162715 15mm 772410, 837780, 897070, 951810 Part # 11-162717 17mm Lots: 311410, 410500, 535530, 712800, 728080, 829580
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution. US nationwide including IA, UT, MN, PA, MO, OK, IL, OH, and WA; CANADA, and NETHERLANDS
  • Descripción del producto
    Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), || 9mm, 11mm, 13mm, 15mm, and 17mm
  • Manufacturer
    Biomet, Inc.

Manufacturer

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