Retiro De Equipo (Recall) de Integra

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 Integra LifeSciences Corp..

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • Causa
    The instructions for use {ifu} {putty part number 7700713001 and strip part number 770151300l for ce marked mozaik strip and putty products contains an incorrect translation of the term "bone marrow aspirate". the term is incorrectly translated in spanish and french,.
  • Acción
    Integra LifeSciences sent a Field Safety Notice letter dated October 11, 2011 to their sole foreign consignee. The letter identified the affected products, problem and actions to be taken. The consignee was asked to remove the existing Instructions for Use (IFU) and replace it with the corrected IFU. The consignee was instructed to complete and return the attached Distributor Rework and Acknowledgment Forms provided with the customer notification letter as documentation that instructions were followed and all required actions were completed. For any questions, call: +33 (0)4 37 47 5900 , fax: +33 (0)4 37 47 5999; or email:


  • Modelo / Serial
    Strip Part Number 7701513001  510 K- K063124 Device Listing Number - D001098  Integra MOZAIKTM Strip IOcc Reference number - CCM I021OITL Batch Number - 105BR0215955  Integra MOZAIKTM Strip 10cc Reference Number - CCM I021OITL Batch Number - 105BR0216149
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Integra Mozaik Strip || 10 cc || Product Usage: || The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.
  • Manufacturer