Z-0155-04

Midwest Tradition PB Fiber Optic High Speed Handpiece with Push Button Chuck (5 tube connection), catalog...

Name: Z-0155-04 Midwest Tradition PB Fiber Optic High Speed Handpiece with Push Button Chuck (5 tube connection), catalog...
Creator: DentSply -Professional Division
Published: 2003-10-14
License: https://open.fda.gov/license/

DentSply -Professional Division / initiated 2003-10-14 / Terminated

FDA source

DentSply -Professional Division began a recall of Midwest Tradition PB Fiber Optic High Speed Handpiece with Push Button Chuck (5 tube connection), catalog #790045 and 790045T; Manufactured for DENTSPLY... on 2003-10-14. The reason FDA records is "Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0155-04
Status: Terminated
Initiated: 2003-10-14
Posted: 2004-07-20
Terminated: 2004-08-03
Recalling firm: DentSply -Professional Division
Product: Midwest Tradition PB Fiber Optic High Speed Handpiece with Push Button Chuck (5 tube connection), catalog #790045 and 790045T; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL 60018-1884 USA
Product code: EFB Handpiece, Air-Powered, Dental
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 root cause: 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: 698 units
Distribution: Nationwide, Canada and Mexico
Product codes and lots: Chuck manufacturing lot numbers 7/15/03, 7/25/03, 8/12/03, 8/14/03; handpiece serial numbers 52336288 through 52429923. Not all units in the serial number range were affected. 446 units were sold new with affected chucks and 252 units were repaired with the affected chucks.

Product code EFB

K963050Class ITradition P, Push Button HandpieceMidwest Dental Products Corp. / cleared 1996-10-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)