Events

Retiro De Equipo (Recall) de Trilogy cups and screws

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
    66500
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1024-2014
  • Fecha de inicio del evento
    2013-10-11
  • Fecha de publicación del evento
    2014-02-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124870
  • 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, metal/polymer, porous uncemented - Product Code LPH
  • Causa
    Zimmer recently conducted a review of all historic packaging validations at its zimmer manufacturing b.V. (zmbv) facility in ponce, puerto rico. based on this review, it was determined that the packaging operations conducted in the building 1 packaging operation at this facility were not properly validated. as a result, zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. the acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. these packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the zmbv facility building 1 packaging operations.
  • Acción
    Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.

Device

Trilogy cups and screws
  • Modelo / Serial
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
  • Descripción del producto
    TRILOGY ACET SHELL 36MM O || TRILOGY ACET SHELL 38MM O || TRILOGY ACET SHELL 40MM O || TRILOGY ACET SHELL 42MM O || TRILOGY ACET SHELL 44MM O || TRILOGY ACET SHELL 46MM O || TRILOGY ACET SHELL 48MM O || TRILOGY ACET SHELL 50MM O || TRILOGY ACET SHELL 52MM O || TRILOGY ACET SHELL 54MM O || TRILOGY ACET SHELL 56MM O || TRILOGY ACET SHELL 58MM O || TRILOGY ACET SHELL 60MM O || TRILOGY ACET SHELL 62MM O || TRILOGY ACET SHELL 64MM O || TRILOGY ACET SHELL 66MM O || TRILOGY ACET SHELL 68MM O || TRILOGY ACET SHELL 70MM O || TRILOGY ACET SHELL 72MM O || TRILOGY ACET SHELL 74MM O || TRILOGY ACET SHELL 76MM O || TRILOGY ACET SHELL 78MM O || TRILOGY ACET SHELL 80MM O || BONE SCREW 4.5X15 SELF-TA || BONE SCREW 4.5X20 SELF-TA || BONE SCREW 4.5X25 SELF-TA || BONE SCREW 4.5X30 SELF-TA || BONE SCREW 4.5X35 SELF-TA || BONE SCREW 4.5X40 SELF-TA || BONE SCREW 4.5X50 SELF-TA || BONE SCREW 4.5X60 SELF-TA || BONE SCREW 6.5X15 SELF-TA || BONE SCREW 6.5X20 SELF-TA || BONE SCREW 6.5X25 SELF-TA || BONE SCREW 6.5X30 SELF-TA || BONE SCREW 6.5X35 SELF-TA || BONE SCREW 6.5X40 SELF-TA || BONE SCREW 6.5X50 SELF-TA || BONE SCREW 6.5X60 SELF-TA || BONE SCREW 6.5X70 SELF-TA || BONE SCREW 6.5X80 SELF-TA
  • 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