Reported Aug 6, 2014 · Terminated
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to…
Novocol, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novocol, Inc. · 416 S Taylor Ave · Louisville, CO · 80027-3028
Is this the product you have?
- 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.
- Lot codes and dates
Product Order Number 950-9119Lot Number C4211-3UPC Code *950-9119*Expiration Date September 2015
- Amount recalled
- 24
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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