Midwest Tradition PB High Speed Handpiece with Push Button Chuck, catalog #790042; Manufactured for DENTSPLY Professiona

FDA device recall Z-0157-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm

DentSply -Professional Division

Reason for recall

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

EFB

Quantity affected

4 units

Distribution

Nationwide, Canada and Mexico

Date initiated

2003-10-14

Date posted

2004-07-20

Date terminated

2004-08-03

Location

Des Plaines, IL