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Recall Observatory FDA recall evidence

Device 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.

Z-2128-2014

July 16, 2014

Class II

Product summary

Firm
Novocol, Inc.
Event
Event 68794
Status
Terminated
Classification
Class II
Quantity
60
Official record key
device-enforcement:Z-2128-2014

Official wording

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

Code information: Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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