Retiro De Equipo (Recall) de Arthrosimplicity Kit

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 Microfixation, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Kit, surgical instrument, disposable - Product Code KDD
  • Causa
    Biomet microfixation, jacksonville, fl is recalling tmj system onpoint scope procedure kit ref 24-3050; tmj system arthrosimplicity kit ref 922070 & 24-4050; tmj system innervue scope procedure kit ref 922090. the onpoint scope kits and arthrosimplicity kits contain chloraprep swabsticks that do not contain any warnings regarding the use of the product on eyes, ears or mouth.
  • Acción
    Biomet Microfixation (formerly W. Lorenz) sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter to the consignees/customers on October 7, 2010. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to fill out the attached Inventory Reconciliation sheet and fax to 904-741-9425 and if the consignees/customers further distributed this product, they should notify their customers and provide them with a copy of this safety alert (the letter must be given to the personnel responsible for receiving field action notices). If you have any questions, please contact the Customer Relations Specialist at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.


  • Modelo / Serial
    All lots prior to 09/14/2010 for Model Number 24-4050.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AL, AR, CA, CO, CT, DC, CR FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD,ME, MI MN, MO, MS, MT, NC, ND, NJ, NY, OH, O K, OR, PA, RI, SC, TN, TX, UT, VA and WA; and countries of: Argentina, Bahrain, Canada, Colombia, Costa Rica, and Finland.
  • Descripción del producto
    "***REF: 24-4050 TMJ SYSTEM ArthroSimplicity KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA***" || Kit Contains: Drape with pouch; 18Gx1.5in needle; OR towel; Towel clips; Skin marker with ruler; Band-aids; Cotton ball; 5ml syringe; Gauze sponges; Extension tubing; Cholarprep swabsticks; Utility Bowl. || All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope.
  • Manufacturer


  • Dirección del fabricante
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • Empresa matriz del fabricante (2017)
  • 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