Events

Rappel de Midwest Tradition PB High Speed Handpiece

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 -Professional Division.

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
    27578
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0157-04
  • Date de mise en oeuvre de l'événement
    2003-10-14
  • Date de publication de l'événement
    2004-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2004-08-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30314
  • 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
    Handpiece, Air-Powered, Dental - Product Code EFB
  • Cause
    Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
  • Action
    Dealers were telephoned on 10/14-16/03 and sent follow-up faxed letters on the same dates. The dealers were informed of the potential for cracked bur chucking mechanisms in the handpieces, requested to examine their stocks for the affected serial numbers, using the faxed list of serial numbers shipped to each account, and return the affected handpieces to DENTSPLY via FedEx. The dealers were also requested to verify the serial number list to those handpieces shipped to customers. If the affected serial numbers were distributed, the customer was requested to supply a list of those customers with contact information to DENTSPLY. As those lists are received by DENTSPLY, end user letters are sent to those customers, informing them of the problem with the bur chucking mechanism and requesting the retutrn of the affected serial numbers for examination and replacement of the bur chucking mechanism if necessary.

Device

Midwest Tradition PB High Speed Handpiece
  • Modèle / numéro de série
    Chuck manufacturing lot numbers 7/15/03, 7/25/03, 8/12/03, 8/14/03; handpiece serial numbers 52327547, 52343124, 52372259, 52417392
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Canada and Mexico
  • Description du dispositif
    Midwest Tradition PB High Speed Handpiece with Push Button Chuck, catalog #790042; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA
  • Manufacturer
    DentSply -Professional Division

Manufacturer

DentSply -Professional Division
  • Adresse du fabricant
    DentSply -Professional Division, 901 W Oakton St, Des Plaines IL 60018-1843
  • Source
    USFDA