Events

Rappel de Device Recall Helioseal Clear

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 Ivoclar Vivadent, 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
    73308
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1026-2016
  • Date de mise en oeuvre de l'événement
    2016-02-12
  • Date de publication de l'événement
    2016-02-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143819
  • 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
    Sealant, pit and fissure, and conditioner - Product Code EBC
  • Cause
    Complaints were received claiming the material failed to polymerize under the curing light. after investigation, it was determined that a wrong photo-initiator was used in the production batch u30755 of helioseal clear. this failure can lead to incomplete curing of the sealant, if mono-wave led curing lights are used.
  • Action
    Ivoclar Vivadent sent an Urgent Medical Device Recall letter dated February 11, 2016, to all consignees via Certified Mail, Return Receipt Requested. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to complete, sign and return the attached acknowledgement form and return it to Ivoclar Vivadent via fax (716) 691-2294 or e-mail at recall.us@ivoclarvivadent.com. Contact Ivoclar Vivadent Customer Service at 1-800-533-6825 as soon as possible between the hours of 8:00 am and 6:00 pm EST Monday through Friday and a representative will arrange to pick up your affected materials for return and credit. Please notify your customers of this issue and return the product to us. For questions, please contact Ivoclar Vivadent Customer Service at 800-533-6825.

Device

Device Recall Helioseal Clear
  • Modèle / numéro de série
    REF/Product Code/Art. No. 558521AN, Lot U29336 (exp. 10/5/2020); REF/Product Code/Art. No. 558520AN, Lots U33966, U35661, U50469 (exp. 10/5/2020)
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.
  • Description du dispositif
    Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
  • Manufacturer
    Ivoclar Vivadent, Inc.

Manufacturer

Ivoclar Vivadent, Inc.