FDAClass IIAugust 6, 2014

Henry Schein Natural Elegance SE Bond Self-Etch recall

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.

Why was Henry Schein Natural Elegance SE Bond Self-Etch recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; Expiration Date September 2015.

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.
Recalling firm
Novocol, Inc.
Quantity
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.
Recall date
August 6, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls