Events

Retiro De Equipo (Recall) de Midwest XGT High Speed Handpiece

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por DentSply -Professional Division.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    27578
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0156-04
  • Fecha de inicio del evento
    2003-10-14
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-08-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30313
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Handpiece, Air-Powered, Dental - Product Code EFB
  • Causa
    Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
  • Acción
    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 XGT High Speed Handpiece
  • Modelo / Serial
    Chuck manufacturing lot numbers 7/15/03, 7/25/03, 8/12/03, 8/14/03; handpiece serial numbers 60007550, 60009370, 110298025 and 600000215 through 600018298. Not all units in the serial number range were affected. 388 units were repaired with the affected chucks.
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Canada and Mexico
  • Descripción del producto
    Midwest XGT High Speed Handpiece with Fiber Optics and Push Button Chuck, catalog #790000; 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
  • Dirección del fabricante
    DentSply -Professional Division, 901 W Oakton St, Des Plaines IL 60018-1843
  • Source
    USFDA