Events

Retiro De Equipo (Recall) de OMNIBotics Tracker Kit

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 OMNI LIFE SCIENCE.

¿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
    75499
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0610-2017
  • Fecha de inicio del evento
    2016-10-14
  • Fecha de publicación del evento
    2016-11-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150547
  • 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
    Orthopedic stereotaxic instrument - Product Code OLO
  • Causa
    Incorrect lot number on outer kit.
  • Acción
    The firm, OMNIlife Science, Inc., issued an "URGENT MEDICAL DEVICE ADVISORY NOTICE" dated 10/14/16 by email to its consignees/customers. U.S. and foreign agents were also sent the notification packet via overnight mail. Acknowledgement of receipt is requested. The notice described the product, problem and actions to be taken. The customers were instructed to immediately quarantine lot 19-09-021 for OMNIBotics Tracker Kit RM-1000; overlabel the outside packaging with the label provided following the provided training paperwork and rework instructions; note advisory notice only includes listed product, it does not affect other lots; and complete and return the Acknowledgement and Receipt Form and accompanying FN-102 by Fax to 508-519-3390. Accounts are to hold item RM-10000 with the lot # 19-09-021 until a corrected label is provided for the outer box. The patient labels inside the box are correct. For further information , Regulatory Affairs Specialist at 774-226-1847 or 800-448-6664 Monday through Friday, 8:00 AM to 4:30 PM, Easter Time.

Device

OMNIBotics Tracker Kit
  • Modelo / Serial
    Lot number: 19-09-021
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.
  • Descripción del producto
    OMNIBotics Tracker Kit -Model: RM-10000 || The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty
  • Manufacturer
    OMNI LIFE SCIENCE

Manufacturer

OMNI LIFE SCIENCE
  • Dirección del fabricante
    OMNI LIFE SCIENCE, 480 Paramount Dr, Raynham MA 02767-1085
  • Empresa matriz del fabricante (2017)
    OMNI LIFE SCIENCE GmbH & Co. KG
  • Source
    USFDA