Events

Rappel de Kerr Revolution Formula 2 Flowable Light Cure Composite

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 Patterson Dental Supply, 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
    57242
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0716-2011
  • Date de mise en oeuvre de l'événement
    2010-10-15
  • Date de publication de l'événement
    2010-12-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95649
  • 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
    Tooth Shade Resin Material - Product Code EBF
  • Cause
    Patterson dental is conducting a recall because they have been advised by the manufacturer of revolution formula 2 (kerr corporation) that some syringes and tips marked with the brand name are not manufactured and distributed by kerr and, thus, not authentic product.
  • Action
    Consignees were sent a Patterson Dental "Urgent Device Recall" letter dated October 15, 2010. The letter was addressed to "Valued Customer". The letter described the product and the problem. It also advised the consignees to quarantine and return the product with the specific distribution dates. Consignees were to complete and return the enclosed Recall Return Form along with the affected product. Questions should be directed to Nancy Strand at 651-686-1966 or nancy.strand@pattersondental.com.

Device

Kerr Revolution Formula 2 Flowable Light Cure Composite
  • Modèle / numéro de série
    Shade A1 - Patterson Item # 434-4719;Kerr Part # 29493 Shade A2 - Patterson Item # 434-4727; Kerr Part # 29494 Shade A3 - Patterson Item # 434-4735; Kerr Part # 29495 Shade B1 - Patterson Item # 434-4768; Kerr Part # 29498
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- Including DC except VT.
  • Description du dispositif
    SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. || SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494. || SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A3, 20 - Dispensing tips, 29495. || SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes B1, 20 - Dispensing tips, 29499. || Revolution is a flowable light cure hybrid resin restorative.
  • Manufacturer
    Patterson Dental Supply, Inc.

Manufacturer

Patterson Dental Supply, Inc.
  • Adresse du fabricant
    Patterson Dental Supply, Inc., 1031 Mendota Heights Rd, Saint Paul MN 55120
  • Société-mère du fabricant (2017)
    Patterson Dental Supply Inc.
  • Source
    USFDA