Events

Rappel de Device Recall CYTCOK TITANIUM POST SYSTEM

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 Dentsply Worldwide Headqrt.

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
    51469
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1234-2009
  • Date de mise en oeuvre de l'événement
    2009-03-20
  • Date de publication de l'événement
    2009-04-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-02-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80334
  • 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 implant components - Product Code ELR
  • Cause
    The product is manufactured with a left-hand thread instead of a right hand thread. this error could cause tooth breakage if the posts were removed without knowing that the threads were reversed.
  • Action
    Dentsply notified their distributors and dentists of the recall by email sent on 03/20/2009 by Urgent Recall Notice letter explaining the problem and requesting return of the product from their inventory and from their consignees. The letter requests faxback response (enclosed with the recall notification) within five (5) working days. The letter included a response page to ensure the receipt of the notice. A second follow up letter will be sent to all that do not respond to the first letter. The firm identified another distributor within the company, DENTSPLY Tulsa Specialty Products, who also sent out identical recall letters to those they distributed the product on 03/25/09.

Device

Device Recall CYTCOK TITANIUM POST SYSTEM
  • Modèle / numéro de série
    C106KL0050A20 (12 posts), Packing Lot Numbers: 2045470, 2457580, 2725900, 2918670, 3032820, 3174500, 3328470, 3626480, and 3779590   C117K00000020 (4 posts), Packing Lot Numbers: 2660790, 3076090, 3231740, and 3797230
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA, Canada, Germany, France, Holland, Switzerland, The Netherlands, Italy, Kuwait, Poland, Argentina, Greece, Russia, Czech Republic, Belgium, Turkey, Hungary, India, and Colombia.
  • Description du dispositif
    Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU): C106KL0050A20 (12 posts) and C117K00000020 (4 posts), Swiss Made, Manufactured for DENTSPLY Maillefer, Johnson City, TN 37604
  • Manufacturer
    Dentsply Worldwide Headqrt

Manufacturer

Dentsply Worldwide Headqrt
  • Adresse du fabricant
    Dentsply Worldwide Headqrt, 221 W Philadelphia St Ste 6, York PA 17401-2992
  • Société-mère du fabricant (2017)
    Dentsply Sirona Inc.
  • Source
    USFDA