Events

Rappel de Device Recall Peak SE Primer Refill

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 Ultradent Products, 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
    62120
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1822-2012
  • Date de mise en oeuvre de l'événement
    2012-05-24
  • Date de publication de l'événement
    2012-06-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109878
  • 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
    Agent, tooth bonding, resin - Product Code KLE
  • Cause
    Ultradent is recalling lot b6z4k of peak se primer as a result of a field complaint, dated may 10, 2012, stating that a syringe of peak se primer was mislabeled as peak lc bond resin. these products are used by dental professionals for bonding needs in restorative dental procedures.
  • Action
    Ultradent Products Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 5, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discard any affected product from their 5135 kit. Customers were asked to complete and return a Recall Return Response form to the firm by fax at 801-553-4609.

Device

Device Recall Peak SE Primer Refill
  • Modèle / numéro de série
    Lot number: B6Z4K.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. || The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.
  • Manufacturer
    Ultradent Products, Inc.

Manufacturer

Ultradent Products, Inc.
  • Adresse du fabricant
    Ultradent Products, Inc., 505 W 10200 S, South Jordan UT 84095-3935
  • Société-mère du fabricant (2017)
    Ultradent Products Inc
  • Source
    USFDA