Events

Rappel de Device Recall Integra NewPort MIS 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 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
    68679
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2182-2014
  • Date de mise en oeuvre de l'événement
    2014-06-27
  • Date de publication de l'événement
    2014-08-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128439
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc - Product Code NKB
  • Cause
    Integra lifesciences is recalling the integra newport mis system because there is a possibility that components from the demonstration set may have been mixed with the newport mis pedicle screw system components used in surgery.
  • Action
    The firm, Integra, sent an "URGENT MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE" dated June 27, to its customers. The letter informs the customers that Integra Lifesciences is recalling the Integra NewPort MIS System because there is a possibility that the components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in the surgery. The letter also informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached response form and return it by email or fax as indicated on the form. Customers with questions regarding the recall letter instructions are instructed to contact the Marketing Manager at (760) 207-7050.

Device

Device Recall Integra NewPort MIS System
  • Modèle / numéro de série
    The affected Serial No.'s are: NWP-016 (NewPort Implant Tray w/ Components) NWP2-015 (NewPort Instrument Tray w/ Components)
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution in TX only.
  • Description du dispositif
    Integra NewPort MIS System || Model No. || NWPIMP (NewPort Implant Tray w/ Components) || NWP2INSTP (NewPort Instrument Tray w/ Components) || The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.