Device 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.
Z-2129-2014
Product summary
- Firm
- Novocol, Inc.
- Event
- Event 68794
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24
- Official record key
device-enforcement:Z-2129-2014
Official wording
Reason: Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Code information: Product Order Number 950-9119; Lot Number C4211-3; UPC Code *950-9119*; Expiration Date September 2015.
Distribution pattern: Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
Derived failure modes
-
Unknown
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.