CLASS II Device recall · Reported 6 Aug 2014 · FDA Enforcement Report
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing recalled
Novocol is recalling Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing, distributed in New York, Pennsylvania, Virginia. The recall was initiated on 16 Jul 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2129-2014
- FDA event ID
- 68794
- Recalling firm
- Novocol, Louisville, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2014
- FDA classified
- 29 Jul 2014
- Reported
- 6 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Dental Devices
Timeline
| 16 Jul 2014 | Recall initiated by company | |
| 29 Jul 2014 | Classified by FDA | +13 days |
| 6 Aug 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
Questions about this recall
Why was it recalled?
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Which lots are affected?
Product Order Number 950-9119; Lot Number C4211-3; UPC Code *950-9119*; Expiration Date September 2015.
Where was it sold?
Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 68794| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure recalled | Novocol | Packaging Defects | NY, PA, VA |
More recalls from Novocol
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure recalled | Novocol | Packaging Defects | NY, PA, VA |
Other Dental Devices recalls
All 426| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |