FDA Medical Device Recalls (openFDA)
Novocol, Inc.: 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.
- Recall number
- Z-2129-2014
- Recalling firm
- Novocol, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-07-16
- Posted
- 2014-07-29
- Terminated
- 2014-12-31
- Reason
- Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
- Root cause
- Process design
- Action
- An email was sent on 7/16/14 to the two distributors requesting the return of all units of Lot C4211-3 in stock.
- Quantity
- 24
- 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.
- Lot, serial or model codes
- Product Order Number 950-9119; Lot Number C4211-3; UPC Code *950-9119*; Expiration Date September 2015.
- 510(k) numbers
- ["K042614"]
- PMA numbers
- not on file
- Product code
- KLE
- Firm FEI
- 1721729
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28