Events

Retiro De Equipo (Recall) de Trabecular Metal

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 Zimmer, 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
    65677
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2055-2013
  • Fecha de inicio del evento
    2013-08-01
  • Fecha de publicación del evento
    2013-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119862
  • 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, non-constrained, metal/polymer cemented - Product Code KWT
  • Causa
    Zimmer is initiating a lot specific recall of the trabecular metal" reverse glenosphere distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. as a result, there is a potential for the device to fail to provide impact to the glenosphere when the trigger is pulled. in addition, there is a potential for the foot of the device to fract.
  • Acción
    Zimmer sent a Urgent Medical Device Recall Notification letter August 1, 2013, and via E-mail and courier to all affected customers. The initial recall notice identified the reason for the recall, possible adverse risks and injuries and informed customers that a replacement will be available in the coming months. In addition, this letter will remind that the instrument is to be lubricated before each use and to inspect the foot. Customers are instructed to inspect any recalled product before and after use for cracks at the foot and ensure the foot is intact. Also ensure all moving parts are lubricated prior to each use according to the Recommendations for Care, Cleaning, Maintenance, and Sterilization Manual 97-5000-170-00. If you find a device which does not function properly or has a damaged foot, provide it to your Zimmer sales representative for return to Zimmer on a Product Experience Report (PER). Questions and concerns should be addressed to the Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST. Phase 2: As devices become available for distribution, a 2nd letter will be sent to the distributors and risk managers. Distributors will be instructed to order replacement devices as a means of completing the affected instrument cases in circulation within their territories. Instructions for the return of devices will be included.

Device

Trabecular Metal
  • Modelo / Serial
    Item # 00-4309-049-00 and Lot Numbers: 60452884, 60461858, 60531990, 60549559, 60605842, 60612781, 60684768, 60754281, 60815778, 60909547, 60959086, 60978338, 61029048, 61135953, 61213252, 61274877, 61334929, 61431672, 61566464, 61594740, 61690097, 61756058, 61857748, 61858851, 61889174, 61906350, 61910781, 61918666 62039450, 62096379, 62101249, 62141887, 62160965, 62215378, 62254111, 62269856, 62304206, and 62311096.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) including the countries of Singapore, Brazil, Taiwan, Australia, Canada, Germany(with further distribution to UAE, Austria, Belgium, Switzerland, Czech Republic, Denmark, Spain, Finland, France, Greece, Israel, Italy, Malta, Norway, Portugal, Sweden and South Africa,
  • Descripción del producto
    00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) || The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid, or damaging the glenoid. Pulling the trigger releases a weight inside the Distractor. This force is transmitted to the bottom of the glenosphere dislodging it from the base plate.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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