Events

Retiro De Equipo (Recall) de Biomet Reverse Humeral Inserter

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
    59724
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3289-2011
  • Fecha de inicio del evento
    2011-08-03
  • Fecha de publicación del evento
    2011-09-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103452
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Recall initiated in response to a biomet canada report, which noted that while testing the instruments, the pin used to secure the implant on the device did not engage on the effected lots and were distributed.
  • Acción
    On 8/3/11 Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers. The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to locate the affected products, discontinue use, return the devices, and a fax a copy of the response form. For information or questions on this recall call Biomet at (574) 372-1570.

Device

Biomet Reverse Humeral Inserter
  • Modelo / Serial
    Part numbers: 406993, Lot numbers:176070 and 657550; and 406993-00, Lot number : 203119.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    International Distribution Only: Canada, Australia, and Columbia.
  • Descripción del producto
    Comprehensive Reverse Humeral Fracture Inserter || REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter QTY 1. || Instrument that is attached to the trial prosthesis for placement in the prepared bone canal to check for correct sizing, version and humeral length. Also used to insert the humeral implant into the canal.
  • 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