FDA Recall Terminated

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

Recall: Z-0157-04 · Initiated October 14, 2003

Recall

Recall Number
Z-0157-04
Event Number
27578
Firm
DentSply Professional Division
FEI Number
1419322
Product Code
EFB
Status
Terminated
Root Cause
Other
Initiated
October 14, 2003
Posted
July 20, 2004
Terminated
August 3, 2004
Address
901 W Oakton St, Des Plaines, IL, 60018-1843

Description

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

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.

Distribution

Nationwide, Canada and Mexico

Quantity

4 units