BEUDAMED
    FDA Recall Terminated

    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: Z-2129-2014 · Initiated July 16, 2014

    Recall

    Recall Number
    Z-2129-2014
    Event Number
    68794
    Firm
    Novocol, Inc.
    FEI Number
    1721729
    Product Code
    KLE
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 16, 2014
    Posted
    July 29, 2014
    Terminated
    December 31, 2014
    Address
    416 S Taylor Ave, Louisville, CO, 80027-3028

    Description

    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.

    Reason

    Septodont is recalling Self-Etch bond because the material was incorrectly packaged.

    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.

    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.

    Quantity

    24