Events

Retiro De Equipo (Recall) de Device Recall Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor

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
    70297
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1208-2015
  • Fecha de inicio del evento
    2015-01-07
  • Fecha de publicación del evento
    2015-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132897
  • 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, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
  • Causa
    The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
  • Acción
    Biomet issued written notices on 1/7/2015, Requested completion and submission of response/effectiveness forms for Product Part Number: 01 0000589 Product Description: Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adapter, Expiration October 2024. Questions related to this notice should be directed to Audrey Daenzer, Field Action Specialist (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Device

Device Recall Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor
  • Modelo / Serial
    Part Number: 010000589 Lot: 527400
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Domestic: AL, FL, NY, TX Foreign: None
  • Descripción del producto
    Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, || Part Number: 010000589 || Lot: 527400
  • 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