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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

FDA Recall Z-0157-04 · Posted 2004-07-20

Recall StatusTerminated
Product CodeEFB
Date Initiated2003-10-14
Date Terminated2004-08-03
Product Quantity4 units

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide, Canada and Mexico

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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