Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, de
FDA device recall Z-0036-2008 · posted 2007-10-02 · Terminated
Recall details
- Recalling firm
- Heraeus Kulzer Inc., Dental Products Division
- Reason for recall
- The material may solidify in the bottle, and thus be rendered unusable.
- Action taken
- Consignees were notified via phone or undated letter sent via fax beginning on or about 7/9/07 and instructed to contact the firm for return authorization/instructions.
- Root cause
- Process design
- Status
- Terminated
- Product code
- KLE
- Quantity affected
- 736
- Distribution
- Nationwide and Canada.
- Date initiated
- 2007-07-09
- Date posted
- 2007-10-02
- Date terminated
- 2008-03-12
- Location
- South Bend, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GLUMA COMFORT BOND + DESENSITIZER (K992292) | Heraeus Kulzer, Inc. | 1999-10-01 |