Events

Retiro De Equipo (Recall) de Biomet Juggerknot in Guide Punch

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
    62391
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2399-2012
  • Fecha de inicio del evento
    2012-08-14
  • Fecha de publicación del evento
    2012-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110399
  • 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
    Punch, surgical - Product Code LRY
  • Causa
    Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.
  • Acción
    Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated August 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return via fax to 574-372-1683. Questions related to the recall should be directed to 574-371-3758, Monday through Friday, 8 a.m. to 5 p.m.

Device

Biomet Juggerknot in Guide Punch
  • Modelo / Serial
    REF. 912064 LOT 121040, 497540, 839530
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.
  • Descripción del producto
    JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. || The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
  • 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