Events

Rappel de OMNIBotics Tracker Kit

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par OMNI LIFE SCIENCE.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75499
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0610-2017
  • Date de mise en oeuvre de l'événement
    2016-10-14
  • Date de publication de l'événement
    2016-11-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150547
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Orthopedic stereotaxic instrument - Product Code OLO
  • Cause
    Incorrect lot number on outer kit.
  • Action
    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
  • Modèle / numéro de série
    Lot number: 19-09-021
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.
  • Description du dispositif
    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