Events

Rappel de Device Recall Breeze SelfAdhesive Resin Cement

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 Kerr/pentron Dba Kerr Corporation And Pentron Clinical.

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
    60242
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0186-2012
  • Date de mise en oeuvre de l'événement
    2011-07-08
  • Date de publication de l'événement
    2011-11-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-06-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104859
  • 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
    Cement, dental - Product Code EMA
  • Cause
    Pentron is voluntarily recalling the breeze self adhesive resin cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product.
  • Action
    Pentron Clinical sent an "Urgent: Medical Device Recall" letter dated July 18, 2011 with an attached Recall Return Form (via USPS First Clas mail) to all affected customers. The letter identified the affected product, explanation of the problem, and actions to be taken. Customers were instructed to discontinue use and return any affected product in their inventory. The letter asks that each customer complete and return the enclosed Recall Return Form via fax to 714-288-4609, in order to confirm receipt of the customer notification. Customers were instructed to contact Pentron Clinical Customer service at (800) 551-0283 (option 1) directly to handle the arrangements of a quick return and replacement.

Device

Device Recall Breeze SelfAdhesive Resin Cement
  • Modèle / numéro de série
    Syringe Lot Number: 3558203 Kit Lot Numbers: 3581367, 3564511, 3538478
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Canada, Cypress, Greece, Germany, Italy, Jordon, Poland, Romania, Turkey and Vietnam.
  • Description du dispositif
    Breeze Self-Adhesive Resin Cement, Part Number: N97A, || Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
  • Manufacturer
    Kerr/pentron Dba Kerr Corporation And Pentron Clinical

Manufacturer

Kerr/pentron Dba Kerr Corporation And Pentron Clinical
  • Adresse du fabricant
    Kerr/pentron Dba Kerr Corporation And Pentron Clinical, 1717 W. Collins Ave, Orange CA 92867
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA