Events

Retiro De Equipo (Recall) de Trilogy F/M Acetabular Shell without holes

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
    63531
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0770-2013
  • Fecha de inicio del evento
    2012-09-14
  • Fecha de publicación del evento
    2013-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114392
  • 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, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • Causa
    Some units of trilogy shells manufactured since march 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). on 10/31/2012, the firm expanded the recall action to include lots of uni-hole trilogy acetabular system shells.
  • Acción
    Zimmer sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated September 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.The firm expanded the scope of the recall in January 2013 to include devices that use a secondary mean of fixation. New recall letters will be submitted to distributors and surgeons.

Device

Trilogy F/M Acetabular Shell without holes
  • Modelo / Serial
    62245445 61633287 61709296 61633288 62252762 61843993 61992773 61761520 62215528 61398137 61338646 00115088 00115232 61403276 62167207 61371922 61807719 62005855 61330613 61490851 61514339 61761502 07892017 61268979 61278050 61278051 61338633 61354843 61384943 61622997 61693498 61730092 61780750 61831580 61581946 62109740 61227827 61645213 61461911 00113594 62252763 62016972 61930133 61236171 61499618 61693502 61926650 61962831 62049520 07892026 61268980 61330614 61371923 61398138 61449976 61490852 61581982 61603351 61629975 61639547 61748057 61772411 61801293 61831567 61851623 61366107 61278052 61278053 62084417 62185026 61227829 61338634 61658815 61476210 62245453 62056760 62030497 61761515 61236172 61366108 61403277 61566835 61596084 61813378 61860182 62011471 07892036 61203322 61268981 61278054 61278055 61281003 61338683 61360704 61371924 61419062 61449979 61490853 61581947 61622960 61633331 61737670 61784845 61831571 61962836 62180913 62078807 61227830 61645214 61476211 11000607 62011479 62042217 07891705 61603352 61278056 61338684 61366109 61769843 61831589 61973149 61236173 61268982 61278057 61278058 61333096 61371925 61514340 61633289 61791914 61813390 61860184 61946161 62084419 62245455 61429360 61645215 61227831 61384944 62270121 11000606 62049525 62005854 62159369 61680959 61851619 61596085 61792009 61236117 61268983 61278059 61278060 61338685 61366110 61371926 61639548 61819016 61398139 62011494 61670759 61950846 61603353 61278061 61419063 61490854 61761519 62126091 61843995 61622961
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.
  • Descripción del producto
    Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. || The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
  • 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