Novocol, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2129-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 16, 2014

Date Posted: August 6, 2014

Recall Number: Z-2129-2014

Event ID: 68794

Reason for Recall:

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

Status: Terminated

Product Quantity: 24

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated