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.
FDA Recall Z-2129-2014 · Posted 2014-07-29
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Recalling FirmNovocol, Inc.
Recall StatusTerminated
Product CodeKLE
Date Initiated2014-07-16
Date Terminated2014-12-31
Product Quantity24
Reason for Recall
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Firm 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.
Root Cause
Process design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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