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U.S. Department of Health and Human Services

Class 2 Device Recall Midwest Tradition PB High Speed Handpiece

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  Class 2 Device Recall Midwest Tradition PB High Speed Handpiece see related information
Date Initiated by Firm October 14, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on August 03, 2004
Recall Number Z-0157-04
Recall Event ID 27578
Product Classification Handpiece, Air-Powered, Dental - Product Code EFB
Product 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
Code Information Chuck manufacturing lot numbers 7/15/03, 7/25/03, 8/12/03, 8/14/03; handpiece serial numbers 52327547, 52343124, 52372259, 52417392
Recalling Firm/
Manufacturer		 DentSply -Professional Division
901 W Oakton St
Des Plaines IL 60018-1843
For Additional Information Contact DENTSPLY Professional Customer Service
800-800-2888
Manufacturer Reason
for Recall		 Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 4 units
Distribution Nationwide, Canada and Mexico
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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