Z-2128-2014Class II

Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50...

Name: Z-2128-2014 Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50...
Creator: Novocol, Inc.
Published: 2014-07-16
License: https://open.fda.gov/license/

Novocol, Inc. / initiated 2014-07-16 / Terminated / root cause: manufacturing process

FDA source

Novocol, Inc. began a recall of Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert on 2014-07-16. FDA classified it as Class II and gives the reason as "Septodont is recalling Self-Etch bond because the material was incorrectly packaged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2128-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-16
Posted: 2014-07-29
Terminated: 2014-12-31
Recalling firm: Novocol, Inc.
Product: Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
Product code: KLE Agent, Tooth Bonding, Resin
Reason for recall: Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Root cause tag: manufacturing process
FDA root 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: 60
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.
Product codes and lots: Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; Expiration Date September 2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2128-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2128-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-29
Z-2129-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-29

Product code KLE

K042614Class IIS&c-Self Etch Pr-BondS & C Polymer GmbH / cleared 2004-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)