Events

Retiro De Equipo (Recall) de Device Recall Trochanteric Nail. Long,

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
    61658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1478-2012
  • Fecha de inicio del evento
    2012-03-30
  • Fecha de publicación del evento
    2012-04-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108656
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    The trochanteric nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation.
  • Acción
    Biomet sent an Urgent Medical Device Recall Notice dated April 18, 2012 to all affected consignees. The letter identified the affected product, reason for the recall including risks involved and actions to be taken. The notice provided directions to immediately locate and return the affected product. Receipt Confirmation was requested by calling 800-348-9500 Ext 3009 or 3983. FAX Back Response Form should be completed and returned to 574-372-1683. Questions should be direct to 574-371-3009 or 574-372-3983, M-F, 8 AM to 5 PM.

Device

Device Recall Trochanteric Nail. Long,
  • Modelo / Serial
    Item 28334, Lot M486130
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - Nationwide (USA)
  • Descripción del producto
    REF 28234 Troch Nail, Long 11MM, Right 34 CM || Peritrochanteric Nail System, Rx Sterile || Biomet Trauma Persippany, NJ || Rod, Fixation, Intramedullary and Accessories || Product Usage: || An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromiummolybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
  • 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