Events

Recall of Midwest XGT High Speed Handpiece

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DentSply -Professional Division.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27578
  • Event Risk Class
    Class 2
  • Event Number
    Z-0156-04
  • Event Initiated Date
    2003-10-14
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30313
  • Notes / Alerts
    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.
  • Extra notes in the data
    Handpiece, Air-Powered, Dental - Product Code EFB
  • Reason
    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 XGT High Speed Handpiece
  • Model / 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.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada and Mexico
  • Product Description
    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
  • Manufacturer Address
    DentSply -Professional Division, 901 W Oakton St, Des Plaines IL 60018-1843
  • Source
    USFDA