Events

Retiro De Equipo (Recall) de Device Recall Indus Invue Screw Caddy

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 SpineFrontier, 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
    65653
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1933-2013
  • Fecha de inicio del evento
    2013-06-21
  • Fecha de publicación del evento
    2013-08-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119818
  • 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
    Tray, surgical, instrument - Product Code FSM
  • Causa
    Difficulty removing screws from the invue caddies.
  • Acción
    SpineFrontier sent a Urgent Invue Caddy Advisory letter dated July 10, 2013, to all affected customers. Customers were advised the removal of the Invue Screw Caddy, SI70097 from the field for modification. Customers were asked to return the parts to SpineFrontier and to complete an Acknowledgement Form indicating that they have read the notice and will initiate the immediate return of the parts noted above. Please feel free to contact us at (978) 232-3990. On 8/21/2013 the recall was expanded.

Device

Device Recall Indus Invue Screw Caddy
  • Modelo / Serial
    Lot Numbers: 7140.014; 6486.008  Recall expanded on 8/21/2013 to include lots: 10754.011; 6417.005R, 7140.005, 6486.007; 6486.007R
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA, including the states of CT, VA, MA, FL, TX, CO and MS. and the country of Jamaica.
  • Descripción del producto
    Indus Invue Screw Caddy, Model: SI70097 || The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws which are separated by type and screw length. The caddy has features to hold the screws in place. || Recall expanded on 8/21/2013 to include additional lots of this product.
  • Manufacturer
    SpineFrontier, Inc.

Manufacturer

SpineFrontier, Inc.
  • Dirección del fabricante
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Empresa matriz del fabricante (2017)
    SpineFrontier, Inc.
  • Source
    USFDA