Events

Retiro De Equipo (Recall) de Device Recall Tornier Latitude Elbow Prosthesis

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 Tornier, 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
    59399
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3082-2011
  • Fecha de inicio del evento
    2011-06-23
  • Fecha de publicación del evento
    2011-08-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102625
  • 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
    Prosthesis, elbow, semi-constrained, cemented - Product Code JDB
  • Causa
    Tornier has discovered that some models of the tornier latitude elbow prosthesis (small and medium humeral stems) were manufactured with a humeral screw that may not function as designed.
  • Acción
    Tornier, Inc. sent an "Urgent Product Correction" letter dated June 23, 2011. The letter was addressed to the doctors. The letter described the product and the problem. Doctors were insructed to monitor patients that have received the units for evidence of humeral screw loosening. For questions customers were instructed to contact the Customer Service Department at 1-888-494-7950.

Device

Device Recall Tornier Latitude Elbow Prosthesis
  • Modelo / Serial
    CC0810047
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including FL and MO
  • Descripción del producto
    Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA. || The Tornier In. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using others techniques. The Tornier In. Latitude Elbow Prosthesis is intended for cemented use only.
  • Manufacturer
    Tornier, Inc

Manufacturer

Tornier, Inc
  • Dirección del fabricante
    Tornier, Inc, 7701 France Ave S Ste 600, Edina MN 55435-3202
  • Empresa matriz del fabricante (2017)
    Wright Medical Group NV
  • Source
    USFDA