Events

Retiro De Equipo (Recall) de Device Recall Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components

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
    66717
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0477-2014
  • Fecha de inicio del evento
    2013-11-12
  • Fecha de publicación del evento
    2013-12-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123122
  • 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, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
  • Causa
    As part of routine manufacturing process monitoring by zimmer, it was discovered that the tibial base and talar components from the total ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. the specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish. this mass media.
  • Acción
    Zimmer sent an URGENT MEDICAL DEVICE RECALL notification letter dated November 12, 2013 to all consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to locate and remove the affected product from their inventory and notify their Zimmer representataive. The Zimmer representative will remove the recalled product from their facility. For patients that previously had the affected product implanted, consignees were instructed to continue their operative follow up routine. Consignees with questions were instructed to call 1-877-946-2761. For questions regarding this recall call 800-613-6131.

Device

Device Recall Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components
  • Modelo / Serial
    Part Number Lot Number 00450004100 62143211 00450004100 62215399 00450004100 62226572 00450004100 62239797 00450004100 62248808 00450004100 62285639 00450004100 62290853 00450004200 62143212 00450004200 62208157 00450004200 62208158 00450004200 62215401 00450004200 62220683 00450004200 62226573 00450004200 62248809 00450004200 62267650 00450004200 62285554 00450004200 62299545 00450004200 62393808 00450004200 62416048 00450004200 62419541 00450004300 62143213 00450004300 62160229 00450004300 62208159 00450004300 62215402 00450004300 62220681 00450004300 62220684 00450004300 62267645 00450004300 62279057 00450004300 62285555 00450004300 62285556 00450004300 62305745 00450004300 62305746 00450004300 62310757 00450004300 62349877 00450004300 62357515 00450004300 62368389 00450004300 62378070 00450004300 62397422 00450004300 62409042 00450004300 62416049 00450004300 62419542 00450004300 62442239 00450004300 62453785 00450004400 62168364 00450004400 62208160 00450004400 62215403 00450004400 62220686 00450004400 62232378 00450004400 62267647 00450004400 62297853 00450004400 62299546 00450004400 62299547 00450004400 62299548 00450004400 62343569 00450004400 62349879 00450004400 62372420 00450004400 62393809 00450004400 62397423 00450004400 62405323 00450004400 62409043 00450004500 62143215 00450004500 62215404 00450004500 62220688 00450004500 62232379 00450004500 62248810 00450004500 62254967 00450004500 62279058 00450004500 62299549 00450004500 62368390 00450004500 62378071 00450004600 62143216 00450004600 62239795 00450004600 62239796 00450004600 62248811 00450004600 62254968 00450004600 62285640 00450004600 62290855 00450004600 62405325 00830004100 62208152 00830004100 62316180 00830004100 62363978 00830004200 62204737 00830004200 62226574 00830004200 62239798 00830004200 62316181 00830004200 62337230 00830004200 62375878 00830004300 62204736 00830004300 62226575 00830004300 62232380 00830004300 62297854 00830004300 62323804 00830004300 62343570 00830004300 62372421 00830004300 62439685 00830004400 62204738 00830004400 62226576 00830004400 62232381 00830004400 62267658 00830004400 62323802 00830004400 62337231 00830004400 62375879 00830004500 62204739 00830004500 62232382 00830004500 62310759 00830004500 62331825 00830004500 62363980 00830004600 62239782 00830004600 62331826 00830004600 62357516
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
  • Descripción del producto
    Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 || Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only.
  • 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