Events

Rappel de Device Recall Maxcem Elite

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 Henry Schein, 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
    60407
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0390-2012
  • Date de mise en oeuvre de l'événement
    2011-11-10
  • 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
    2018-07-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105261
  • 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 specific lots of maxcem elite refill kit appear not to be authentic.
  • Action
    The firm, Henry Schein, Inc., sent an "URGENT: Product Recall (Dental Practitioners/User Level) letter and response form dated November 10, 2011, via first class mail to its customers. The letter instructed the customers to examine their inventory to verify if they have any of the specified lots on hand. If so, remove it from their shelves. The product may be returned for credit within 30 days, to the following address: Henry Schein, Inc., 41 Weaver Road, Denver, PA 17517. Additionally, the letter instructed the customers to complete, sign, date, and return the enclosed Henry Schein Response Form via fax to: (631) 843-5557 or mail to: Regulatory Affairs Department (E-355) 135 Duryea Road, Melville, NY 11747, Attn: Regulatory-RR. The letter stated "Only returns of the above noted recalled item/lot numbers purchased from Henry Schein, Inc. will be credited to your account. In order to expedite your credit, please include a copy of your response form and invoice, if available, with your return". If you have any questions regarding this matter, please contact Recall Coordinator at 631-390-8000 ext. 8476.

Device

Device Recall Maxcem Elite
  • Modèle / numéro de série
    Lot numbers 3285932 (exp. 01/2011), 3461229 (exp. 11/2011), 3566373 (exp. 05/2012) ; HSI number 123-7426
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Bermuda, Martinique FWI, Nassau Bahamas, St Maarten NA, Australia, and South Africa.
  • Description du dispositif
    Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips (wide) 4:1, 10 Intra-oral tips || Dental resin cement. Self-etch, self-adhesive resin cement. High bond strength without adhesive needed. Easy to clean up and can be used with all anterior and posterior ceramics, PFMs, and CAD/CAM materials. Color stable and aesthetic. Works with all substrates from opaque to translucent.
  • Manufacturer
    Henry Schein, Inc.

Manufacturer

Henry Schein, Inc.
  • Adresse du fabricant
    Henry Schein, Inc., 135 Duryea Rd, Melville NY 11747
  • Société-mère du fabricant (2017)
    Henry Schein Inc
  • Source
    USFDA