Recall Z-2129-2014 ยท KLE Agent, Tooth Bonding, Resin
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.
| Date | Jul 29, 2014 (initiated Jul 16, 2014) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042614 | S&C-SELF ETCH PR-BOND S & C Polymer GmbH, Nov 22, 2004 |