DentSply Professional Division 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.

Recommended Action

Per FDA guidance

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.