Events

Rappel de Microseal Master Cone Part Number: 8159033

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 Ormco 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
    57234
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0160-2012
  • Date de mise en oeuvre de l'événement
    2010-09-09
  • Date de publication de l'événement
    2011-11-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95651
  • 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
    Gutta-percha - Product Code EKM
  • Cause
    The recall was initiated because sybronendo has confirmed that the microseal master cones has been mislabeled.
  • Action
    Sybron Dental Specialties, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated September 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return the affected lots of product.. Products, would be replaced at no charge or credited to their account. Customers were instructed to contact SybronEndo Customer Care at 1-800-346-3636 directly to handle the arrangements of a quick return and replacement. The affected product should be returned to SybronEndo at the following address. Please label returned product "RECALLED PRODUCT Attention: Customer Returns" SybronEndo 1332 South Lone Hik Avenue Glendora, CA 91740 ADDITIONALLY, THEY KINDLY REQUEST CONSIGNEE COOPERATION IN COMPLETING AND FAXING BACK THE ENCLOSED ACKNOWLEDGEMENT/RETURN FORM. THIS FORM MUST BE COMPLETED AND RETURNED WHETHER OR NOT YOU HAVE ANY PRODUCT TO RETURN. Customers were also asked to identify and recover the affected product lots listed above that may have been shipped to their customers. For questions regarding this recall call 909-962-5600.

Device

Microseal Master Cone Part Number: 8159033
  • Modèle / numéro de série
    Lot Numbers: 111507, 082307
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AR, CA, FL, PA, GA, IL, TX, WA, NY, IN, AL & MT; Internationally to Canada, CIS (Commonwealth of Independent States, Israel, United Kingdom, Sweden, France, Germany, and Italy.
  • Description du dispositif
    Microseal Master Cone Part Number: 815-9033 || Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.
  • Manufacturer
    Ormco Corporation

Manufacturer

Ormco Corporation
  • Adresse du fabricant
    Ormco Corporation, 1332 S Lone Hill Ave, Glendora CA 91740
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA