Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing — Class II medical device recall Z-2129-2014
Terminated recall by Novocol, Inc., reported 2014-08-06, distributed in NY, PA. Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
| Recall number | Z-2129-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novocol, Inc., Louisville, CO, United States |
| Recall initiated | 2014-07-16 |
| Classified | 2014-07-29 |
| Reported by FDA | 2014-08-06 |
| Terminated | 2014-12-31 |
| Distributed | NY, PA |
| Quantity | 24 |
| Lot numbers | C4211-3 |
| Expiration dates | 2015-09-20 |
Product
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.
Reason for recall
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2129-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.