Events

Retiro De Equipo (Recall) de Device Recall Conformis

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 Conformis 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
    62576
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2222-2012
  • Fecha de inicio del evento
    2012-07-17
  • Fecha de publicación del evento
    2012-08-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111079
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    Addendum labeling itotal cr surgical technique with detailed instructions of total cr poly insertion technique.
  • Acción
    ConforMIS sent an Urgent Field Safety Notice letter dated July 5, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. An Addendum is included that provided updates to the Surgical Technique Guide. The updated technique guide will be delivered to all iTotal surgeons along with an on-site vist from ConforMIS sales representative. Customers were instructed to place the Surgical Technique Guide Addendum alongside the surgical plan, it puts the information in a highly visible location for the surgeon to review prior to the surgical procedure. Customers were asked to sign the communication verification form attached. For any questions regarding this notice, please contact your local ConforMIS representative or MDSS GmbH, Tel.: +49-511-62628630, info@mdss.com.

Device

Device Recall Conformis
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide and the country of Germany
  • Descripción del producto
    Conformis iTotal CR-Cruciate Retaining Knee Replacement System || Model Numbers: || M57250600010 iTotal CR, Left Knee || M57250600020 iTotal CR, Right Knee || Product Usage : Usage: || The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis.
  • Manufacturer
    Conformis Inc

Manufacturer

Conformis Inc
  • Dirección del fabricante
    Conformis Inc, 1 North Ave, Suite B, Burlington MA 01803-3305
  • Empresa matriz del fabricante (2017)
    Conformis Inc
  • Source
    USFDA