Class 2 Device Recall Septodont aka Novocol

• Date Initiated by Firm: July 16, 2014
• Date Posted: July 29, 2014
• Recall Status: Terminated on December 31, 2014
• Recall Number: Z-2129-2014
• Recall Event ID: 68794
• 510(K)Number: K042614
• Product Classification: Agent tooth bonding, resin - Product Code KLE
• 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.
• Code Information: Product Order Number 950-9119; Lot Number C4211-3; UPC Code *950-9119*; Expiration Date September 2015.
• Recalling Firm/ Manufacturer: Novocol, Inc.; 416 S Taylor Ave; Louisville CO 80027-3028
• For Additional Information Contact: Arsalan Rizvi; 303-665-7535 Ext. 214
• Manufacturer Reason for Recall: Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KLE