Events

Rappel de Device Recall Dental cement under the brand name CementIt and Natural Elegance

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
    60359
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0454-2012
  • Date de mise en oeuvre de l'événement
    2011-03-17
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105131
  • 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
    The firm initiated a recall because the product sets faster than specified in the "directions for use" and in release specifications.
  • Action
    The firm, Pentron Clinical, sent an " URGENT: MEDICAL DEVICE RECALL" letters dated April 4, 2011 and April 20, 2011 via USPS 1st class mail to its customers. The letter describes the product, problem and actions to be taken. The letter instructed customers to review the table with affected product lots and determine if the affected products was in their inventory; return the affected product for a replacement at no charge; contact Pentron Clinical Customer Service at (800) 551-0283; 1-800-243-3969 ext. 677 or email: aestridge@pentron.com directly to handle the arrangements of a quick return and replacement; and complete and fax back the enclosed Recall Return Form at 1-877-677-8844. The letter also request the customer to identify and recover the affected product lots that may have been shipped to thier customers. If you have any questions, contact Pentron Clinical Customer Service at (800) 551-0283.

Device

Device Recall Dental cement under the brand name CementIt and Natural Elegance
  • Modèle / numéro de série
    Product under the brand name Cement-It: Part No. N33, N33A; Syringe Lot No. 183058; Package Lot No. 186272, 186665, 186676.  Product under the brand name Natural Elegance (Private Label of Cement-It): Part No. SHN9004110; Syringe Lot No. 183058; Package Lot 182990, 186133, 188996.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: PA, IL, NV, WA, OH, TN, WI, NY, NJ, CT, IN FL, MI, OK, NE, HI, VA, CA, and TX; and countries of : Canada, Egypt, Isreal, Netherlands, Sweden and UK.
  • Description du dispositif
    Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). || The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural Elegance (private label of Cement-It) are indicated as a luting cement bonding system for porcelain crowns, inlays, and onlays and other dental restorations, including ceramics, metal alloys and composite restoratives.
  • 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