Events

Rappel de Integra Surgical

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
    60214
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0373-2012
  • Date de mise en oeuvre de l'événement
    2011-10-10
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104770
  • 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
    Light, surgical, fiberoptic - Product Code FST
  • Cause
    Headlight assembly (module) may become loose and separate from the headband assembly.
  • Action
    Integra Life Sciences notified consignees by URGENT DEVICE RECALL letter dated October 10, 2011, via FedEx, email or telephone conference calls. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to identify and return any affected product. Customers were requested to complete and return the attached Field Corrective Action Acknowledgement Form to Integra Surgical indicating receipt and review of this notification. For assistance and additional information contact your local and Integra Sales Representative or call Integra Surgical Customer Service at 1-800-431-1123.

Device

Integra Surgical
  • Modèle / numéro de série
    All serial numbers
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of: Africa, Algeria, Australia, Austria, Brazil, Canada, Check Republic, China, Chile, Costa Rica, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece Hungary, Guatemala, India, Ireland, Israel, Italy, Iraq, Japan, Jordan, Kenya, Kuwait, Lebanon, Lithuania, Macedonia, Mexico, Netherlands, New Zealand! Norway, Oman, Pakistan, Peru Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Qatar, United Kingdom, Yemeni United Arab Emirates, Uruguay, and Venezuela.
  • Description du dispositif
    UltraLite Headlight module-grey || Model: 001328 || Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.