Home / Recalls / Novocol, Inc. / Z-2129-2014

Z-2129-2014 Class II Terminated

Recalled by Novocol, Inc. — Louisville, CO

Recall Details

Product Type: Devices
Report Date: August 6, 2014
Initiation Date: July 16, 2014
Termination Date: December 31, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 24

Product 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 for Recall

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

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.

Code Information

Product Order Number 950-9119; Lot Number C4211-3; UPC Code *950-9119*; Expiration Date September 2015.