Recall Z-2129-2014
Novocol, Inc. · initiated July 16, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product Order Number 950-9119; Lot Number C4211-3; UPC Code *950-9119*; Expiration Date September 2015.
Reason for recall
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
FDA-determined cause: Process design
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.
Details
- Recall number
- Z-2129-2014
- Initiated
- July 16, 2014
- Posted by FDA
- July 29, 2014
- Terminated
- December 31, 2014
- Product code
- KLE – Agent, Tooth Bonding, Resin
- 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.
- Recalling firm
- Novocol, Inc., Louisville, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2128-2014 Class II | Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL…Septodont is recalling Self-Etch bond because the material was incorrectly packaged. | 07/16/2014Terminated |