FDA Medical Device Recalls (openFDA)
DentSply -Professional Division: 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
- Recall number
- Z-0155-04
- 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
- Status
- Terminated
- Initiated
- 2003-10-14
- Posted
- 2004-07-20
- Terminated
- 2004-08-03
- Reason
- Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
- 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
- 698 units
- Distribution
- Nationwide, Canada and Mexico
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K963050"]
- PMA numbers
- not on file
- Product code
- EFB
- Firm FEI
- 1419322
- Firm city
- Des Plaines
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28