Events

Rappel de Device Recall Maxcem Elite, a dental 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 Corporation.

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
    60685
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0915-2012
  • Date de mise en oeuvre de l'événement
    2011-02-03
  • Date de publication de l'événement
    2012-01-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106203
  • 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
    Dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief - Product Code MZW
  • Cause
    The recall was initiated because kerr corporation has confirmed that the use of the affected lot of maxcem elite may not provide users with a minimum of 2 minutes of work¿time thereby causing the product to prematurely set by 15 seconds.
  • Action
    Kerr Corporation sent a Urgent Medical Device Recall letter dated March 14, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It has recently come to our attention that use of the affected lot of product may not provide users with a minimum of 2 minutes of work¿time thereby causing the product to prematurely set by 15 seconds. If this were to happen prior to placing restorations on the tooth or core build-up the restorations may not adhere properly. If you have any of the affected product listed above please contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit. Please fax back the enclosed Recall Return Form in order to confirm your receipt of this recall notification regardless of whether you have any product in your inventory.

Device

Device Recall Maxcem Elite, a dental cement
  • Modèle / numéro de série
    Lot Number 3360900
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of Canada, Australia and New Zealand.
  • Description du dispositif
    Brand name: Maxcem Elite, || Product: a dental cement, || Part Number: 34418. || The intended use of this device is for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts and veneers. Additional Indications include core-buildup material, pit and fissure sealant and cementation of crown restorations to implants
  • Manufacturer
    Kerr Corporation

Manufacturer

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