Events

Rappel de Flow Tec

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 Sybron Dental Specialties.

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
    59936
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1007-2012
  • Date de mise en oeuvre de l'événement
    2010-10-22
  • Date de publication de l'événement
    2012-02-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104069
  • 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
    Material, tooth shade, resin - Product Code EBF
  • Cause
    The recall was initiated because pentron clinical has confirmed the flow tec nano hybrid flowable composite material has been found to be difficult to extrude.
  • Action
    Sybron Dental sent a Recall Letter dated November 15, 2010 to consignees informing them of the above mentioned public reason for recall and asking them to determine if they have any affected products in their inventory and requesting their cooperation in returning any affected product which they still have in their stock. Product was to be returned and replaced at no charge. They also requested that consignees complete and fax back an enclosed return from , whether or not they had any product to return. Consignees were told to call Pentron Customer Service at (800) 551-0283 directly to handle the arrangements of a quick return and replacement. Authorized Petron Clinical distributors were asked to identify and recover the affected product lots that may have been shipped to their customers.

Device

Flow Tec
  • Modèle / numéro de série
    Syringe Lot Number: 165741 Package Lot Numbers: 165257, 165293, and 165937
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Cyprus, Germany, Italy, Poland, Canada, Ecuador, and Kuwait
  • Description du dispositif
    Flow Tec Part Number 3786-754, Syringe Lot Number 165741 || The intended use of the device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artist Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties
  • Adresse du fabricant
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA