Events

Rappel de CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL)

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 Corporation.

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
    62978
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2428-2012
  • Date de mise en oeuvre de l'événement
    2012-08-09
  • Date de publication de l'événement
    2012-09-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-03-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112195
  • 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 stereotaxic Instrument - Product Code HAW
  • Cause
    T-handle screw is used on a complementary product to the crw, the integra hraim, which is the ct-compatible intubation head ring assembly. when the t-handle on the hraim intubation hoop is tightened, the t-handle could stop in a vertical position that prevents the crwprecise and certain models of the crw-asl from seating properly on the head ring although it appears to be fully seated.
  • Action
    The firm, Integra, sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" dated August 10, 2012 to US & Canada consignees/customers via traceable courier service and Non-US & Non-Canada consignees/customers - through written notification delivered either by traceable courier, email, facsimile, or through a directed visit by an Integra Sales Representative. The notification describes the product, problem and actions to be taken. The Integra sales representative will replace the screws according to the attached rework instructions. If for some reason it is not possible to replace the screws during the visit, the sales representative will leave the screws and customers can then replace them by following the attached rework instructions and discard the old screws immediately after replacement. The customers were instructed to complete and return the Product Recall Acknowledgement Form via the sales representatives visit; fax at 1-609-750-7999 or email to: csnirecalls@integralife.com and include the number of devices to be identified and replaced . Note:The T -Handle screws that are replaced will be disposed of at the consignee's/customers location. Please feel free to contact our service hotline at 888-772-7378 should you have any additional questions.

Device

CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL)
  • Modèle / numéro de série
    All lot numbers from 2002 to current
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.
  • Description du dispositif
    Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts || The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation