Events

Retiro De Equipo (Recall) de Device Recall OSS Cemented IM Stem

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
    60447
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0417-2012
  • Fecha de inicio del evento
    2011-11-01
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105423
  • 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, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
  • Causa
    Biomet has initiated this action following an investigation which identified that part 150367, (oss cemented 1m stem 13x150) was incorrectly labeled as part 150368 (oss cemented 1m stem 14x150).
  • Acción
    Biomet, Inc. sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 1, 2011 to the one distributor with the affected product. The letter described the product, problem, and actions to be taken by the customer. The letter instructs the customer to immediately locate and remove the affected product from inventory. Additionally, the customer was asked to complete and return a Response Form via fax to 574-372-1683. Call 574-372-3983 for questions related to this notice.

Device

Device Recall OSS Cemented IM Stem
  • Modelo / Serial
    Item: 150368; Lot 081650
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed only in The Netherlands.
  • Descripción del producto
    OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. || Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cemented applications.
  • 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