Events

Retiro De Equipo (Recall) de 4 0 MM X 14 MM Variable Screw CTek Maxan Anterior Cervical Plate System.

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 Spine, LLC.

¿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
    71940
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2744-2015
  • Fecha de inicio del evento
    2015-08-05
  • Fecha de publicación del evento
    2015-09-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139414
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Causa
    Some of p/n 14-521614b lot 375440 was mislabeled as p/n 14-521614 lot 375440.
  • Acción
    Zimmer Biomet sent an Urgent Medical Device Recall Notice dated August 5, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by customer. Customers were instructed to immediately locate and discontinue use of the affected product. This action requires the immediate location and discontinued use of the item and its immediate return to Zimmer Biomet Spine. Specifically, customers were REQUIRED to take the following steps: " Immediately locate and remove from circulation the items consigned/loaned to your account as identified on page two of this notice. " Carefully follow the instructions on the enclosed "Response Form". " If you have further distributed these items to medical facilities, you MUST notify them of this action. This letter MUST be given to the person responsible for receiving recall notices. However, you are charged with the location and return of these items. Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone: Online: Fax: Phone: Regular Mail: www. fda .gov /MedWatch/report.htm (800) FDA-0178 (800} FDA-1088 Use postage-paid FDA form 3500 available at www.fda.gov/Medwatch/getforms.htm and mail to Medwatch, 5600 Fishers Lane, Rockville, MD 20852-9787. Questions related to this notice should be directed to 303-501-8400 Monday through Friday, 8 a.m.to 5 p.m. MST. Zimmer Blomet

Device

4 0 MM X 14 MM Variable Screw CTek Maxan Anterior Cervical Plate System.
  • Modelo / Serial
    Model Number 14-521614B, lot number 375440.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA.
  • Descripción del producto
    Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
  • Manufacturer
    Biomet Spine, LLC

Manufacturer

Biomet Spine, LLC
  • Dirección del fabricante
    Biomet Spine, LLC, 310 Interlocken Pkwy Ste 120, Broomfield CO 80021-3464
  • 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