Events

Retiro De Equipo (Recall) de Sequoia final driver closure top retention

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
    58376
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2705-2011
  • Fecha de inicio del evento
    2011-04-04
  • Fecha de publicación del evento
    2011-06-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99235
  • 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
    Instrument, surgical, non-powered - Product Code HAO
  • Causa
    A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. when the hex tip of the screwdriver is not fully engaged and/or the screwdriver is used off axis, the hex tip of the screwdriver can become rounded or partially rounded.
  • Acción
    The firm, ZIMMER, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 4, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that each instrument tray had both final drivers (with and without retention feature); contact their customer service representative if they do not have both versions; ensure proper seating of the drive by moving the driver side to side, and complete and return the Distributor Certification Form via fax to: Zimmer Spine at 512-258-0995. The letter states the firm will be distributing the version of the screwdriver with no retention feature beginning in March 2011 and distributing the new surgical technique in April 2011. The firm is including an additional final driver in the instrument tray for final tightening of the closure tops. Please keep Zimmer Spine informed of any adverse events associated with the device or any other Zimmer spine product by calling 800-326-0635. For any further questions or concerns contact the Vice President Quality Assurance & Regulatory Affairs at 800-655-2614.

Device

Sequoia final driver closure top retention
  • Modelo / Serial
    60LJ, 60LK, 60LL, 61HZ, 61RS, 64DC, 64DC.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including the states of: AL, AZ, CA, CT, CO, FL, GA, LA, MI, MN, MO, NC, NY, OH, OK, PA, TN, TX, WA and WI; and countries of: Czech Republic, Denmark, France, Singapore, Spain, Switzerland, and United Kingdom.
  • Descripción del producto
    Sequoia final driver closure top retention, non-sterile, REF 3384-2, Zimmer Spine, Austin, Texas, The device is used to apply final torque to closure tops of the implant. || The Sequoia Final Driver is used in conjunction with a counter torque tube to apply final torque to closure tops that secure the rod component to the screw head component until the torque limiting handle pops once, indicating the implant has been locked. This process is repeated with all closure tops in a construct (assembly). The Sequoia Final Driver is also used to tighten the set screw feature and lateral locking cams on the SpeedLinkII transverse connectors when used and is used to remove previously inserted closure tops during construct removal.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Dirección del fabricante
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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