Events

Retiro De Equipo (Recall) de Device Recall Speedpass Suture Lariat

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, 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
    56193
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2229-2010
  • Fecha de inicio del evento
    2010-06-18
  • Fecha de publicación del evento
    2010-08-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92908
  • 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
    Manual Surgical Instrument for General Use - Product Code MDM
  • Causa
    The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable and possibly delaying surgery.
  • Acción
    The firm notified all 29 consignees by An Urgent Medical Device Recall Notice letter on 6/18/2010. The letter identified the affected product and explained the reason for recall. Customers are asked to locate and remove the affected products, follow the instructions on the enclosed "FAX Back Response Form," and fax a copy of the form back prior to return of the affected product. Additionally, if product has been further distributed, then hospital personnel must be notified and given the "Dear Biomet Customer" letter. Questions should be directed to Mary Johnson at 800-348-9500 or 574-372-3983.

Device

Device Recall Speedpass Suture Lariat
  • Modelo / Serial
    Lot numbers: 050260, 863960, and 863970.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including the states of FL, IL, NY, CO, MD, CA, GA, AL, PA, OH, SD, KY, TX, ID, WA, NC, AK, & MN, and Columbia and The Netherlands.
  • Descripción del producto
    SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, QTY. 1, Biomet Sports Medicine, Warsaw, IN 46581. Sterile. Part number 904010. || Used to pass suture through tissue.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Dirección del fabricante
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 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