Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator b
FDA device recall Z-2128-2014 · posted 2014-07-29 · Terminated
Recall details
- Recalling firm
- Novocol, Inc.
- Reason for recall
- Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
- Action taken
- An email was sent on 7/16/14 to the two distributors requesting the return of all units of Lot C4211-3 in stock.
- Root cause
- Process design
- Status
- Terminated
- Product code
- KLE
- Quantity affected
- 60
- Distribution
- Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
- Date initiated
- 2014-07-16
- Date posted
- 2014-07-29
- Date terminated
- 2014-12-31
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| S&C-SELF ETCH PR-BOND (K042614) | S & C Polymer GmbH | 2004-11-22 |