Events

Retiro De Equipo (Recall) de Tornier AFFINITI Humeral Head

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 Tournier, 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
    50232
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0834-2009
  • Fecha de inicio del evento
    2008-10-20
  • Fecha de publicación del evento
    2009-01-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75044
  • 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
    shoulder, prosthesis - Product Code KWS
  • Causa
    Tornier, medical has received a report of a mislabeled sterile affiniti head product. as a result, tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of affiniti stems.
  • Acción
    An Urgent Product Recall letter, dated 10/17/08, was hand delivered to end users by distributors and sales representatives beginning 10/20/08. The recall letter identified the issue and requested end users to immediately discontinue use of the affected products and return any unused affected products to Tornier. Distributors were to notify any and all accounts that may be end users or to provide this information to Tornier, whom will contact the end users. A questionnaire and return instructions were provided with the letter. The questionnaire was asked to be completed and returned to Tornier as soon as possible. For additional information, contact Tornier Customer Service at 1-888-494-7950.

Device

Tornier AFFINITI Humeral Head
  • Modelo / Serial
    Lot No.: AA1298
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI
  • Descripción del producto
    Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020057. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
  • Manufacturer
    Tournier, Inc.

Manufacturer

Tournier, Inc.