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Recall Observatory FDA recall evidence

Device 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.

Z-2129-2014

July 16, 2014

Class II

Product summary

Firm
Novocol, Inc.
Event
Event 68794
Status
Terminated
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-2129-2014

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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