Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.
FDA device recall Z-0313-2007 · posted 2006-12-27 · Terminated
Recall details
- Recalling firm
- Stardental Division
- Reason for recall
- End cap component can disassemble.
- Action taken
- The recalling firm sent recall letters to dealers and doctors via certified mail, return receipt on 12/6/06. Letters to the foreign accounts were sent via UPS or other traceable methods.
- Root cause
- Other
- Status
- Terminated
- Product code
- EFA
- Quantity affected
- 2756 end caps
- Distribution
- Worldwide distribution, including USA, Canada and Japan.
- Date initiated
- 2006-12-01
- Date posted
- 2006-12-27
- Date terminated
- 2007-06-12
- Location
- Lancaster, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES (K960507) | Dentalez Group | 1996-03-28 |
| STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE (K960719) | Dentalez Group | 1996-03-28 |