Recall Z-0155-04 ยท EFB Handpiece, Air-Powered, Dental
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
| Date | Jul 20, 2004 (initiated Oct 14, 2003) |
| Status | Terminated |
| 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 w |
| Quantity | 698 units |
| Distribution | Nationwide, Canada and Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963050 | TRADITION P, PUSH BUTTON HANDPIECE Midwest Dental Products Corp., Oct 11, 1996 |