Events

Retiro De Equipo (Recall) de Device Recall TMJ SYSTEM 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
    Recall
  • ID del evento
    53584
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0530-2010
  • Fecha de inicio del evento
    2009-01-09
  • Fecha de publicación del evento
    2009-12-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85914
  • 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, inc. is recalling their onpoint tmj kit (part numbers 24-3050, 24-3055) and arthrosimplicity tmj arthocentesis kit (part numbers 922070, 922090, 922075). these two kits contain a bd sterile disposable 60 ml luer-lok syringe, part number 309653 which is under recall by becton dickinson (recall number z-2347-2008). becton dickinson has determined that unit package seal integ.
  • Acción
    Consignees were notified by a combination of telephone, fax, e-mail and certified mail. Questions related to this notice should be directed to Christy Cain at 1-800-874-7711.

Device

Device Recall TMJ SYSTEM ARTHROSIMPLICITY Kit
  • Modelo / Serial
    BP Syringe Codes 7298534, 7334153. Kit Lot #: 1107001,  1107002,  539500,  542870  542880  543090,  554890,  554900,  554920,  554930,  554940,  554950,  554970,  554980,  554990,  555000,  555010,  555020,  555030,  557720,  557730,  557750,  557790,  557800,  557810,  557820,  557830,  560540,  560550,  560560,  577500,  577510,  577520,  577530,  577560,  577590,  577600,  577610,  577620,  577630,  577640,  577650,  577660,  577680,  577690,  637110,  637120,  661250,  661270,  662960,  666880,  667830,  667850,  685230,  685240,  685250,  685260,  685770,  685780,  685790,  685800,  685810,  685820,  554870,  554880,  554910,  554960,  557780,  577540,  577550,  577570,  577580,  637130,  685760, and 698200.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was distributed Internationally to Argentina, Denmark, Norway, and UK. Product was distributed domestically to AL, CA, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, MO, MS, NC, OH, NY, PA, SC, TN, TX, UT, and VA.
  • Descripción del producto
    BD Recalled component is labeled: || BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. || BD Franklin Lakes, NJ 07417 USA Made in USA , www.bd.com. || Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. || Component is found in: || TMJ SYSTEM ARTHROSIMPLICITY KIT REF 922070, STERILE PRODUCT, CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. || DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com || Kit contains individually packaged sterile products. || Kits are for lysis and lavage; the syringe is used for pumping saline into the joint.
  • Manufacturer
    Biomet Microfixation, Inc.

Manufacturer

Biomet Microfixation, Inc.
  • Dirección del fabricante
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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