Events

Rappel de Device Recall KyphX Osteo Introducer System

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 Kyphon Inc.

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
    48988
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2347-2008
  • Date de mise en oeuvre de l'événement
    2008-06-23
  • Date de publication de l'événement
    2008-09-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-10-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72455
  • 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 manual surgical instrument. - Product Code LXH
  • Cause
    Some products may contain the incorrect introducer stylet. if the treating physician is unfamiliar with the use and design of the diamond tip stylet, there is a possibility of serious injuring occurring with the use of the diamond tip stylet during balloon kyphoplasty procedure. other risks include delay to surgery and inconvenience to patient.
  • Action
    Recall initiated on June 23, 2008. A recall letter and reconciliation form was sent out via e-mail to sales representatives for hand delivery to US hospital consignees. The consignees were asked to review the letter and complete/return the reconciliation form to the firm. If you have any questions contact Kyphon, Inc. at 1-408-548-6740.

Device

Device Recall KyphX Osteo Introducer System
  • Modèle / numéro de série
    Lot code J8052810
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Class II Recall - Nationwide Distribution.
  • Description du dispositif
    KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device is used to access vertebral body during balloon kyphoplasty, a procedure designed to reduce and stabilize vertebral body compression fractures (VCFS).
  • Manufacturer
    Kyphon Inc

Manufacturer

Kyphon Inc
  • Adresse du fabricant
    Kyphon Inc, 1221 Crossman Ave, Sunnyvale CA 94089-1103
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA