Events

Rappel de Device Recall Integra Radionics

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 Integra LifeSciences Corp..

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
    57818
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1400-2011
  • Date de mise en oeuvre de l'événement
    2011-01-12
  • Date de publication de l'événement
    2011-02-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97501
  • 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
    Neurological, sterotaxis instrument - Product Code HAW
  • Cause
    Overall length of the intubation hoop in the hraim intubation head ring assembly is too long and will not allow a device to to attach.
  • Action
    Integra sent a Medical Device Field Corrective Action letter dated January 12, 2011, to all affected customers via Federal Express. Integra Sales Specialists were provided with the replacement part and written instructions on how to replace the affected intubation hoops from customer inventory identified in the traceability report. Upon completion of the field correction each sales specialist was instructed to return the affected hoop along with a completed copy the Recall Acknowledgement and Return Form. If additional information is required contact me at (609) 936-2485 or james.tillman@integraJife.com.

Device

Device Recall Integra Radionics
  • Modèle / numéro de série
    Lot/Serial Number(s): 0189463, 0189289, 0186642, 0184885
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, Canada, and Australia
  • Description du dispositif
    Integra Radionics HRAIM Intubation Head Ring Assembly || Ref: HRAIM Head Rings serve as the general stereotactic treatment platform. Head Rings are used to provide a reference frame for instrumentation used for precise spatial localization and treatment of physiologic targets for stereotactic neurosurgical procedures such as craniotomies, biopsies, functional neurosurgery, and radiation therapy. Head Rings are delivered to the user non-sterile, and are reusable.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.