Septodont Recalls Compolite Bond SE Due to Incorrect Packaging
Septodont is recalling 24 units of Compolite Bond SE dental adhesive because the material was incorrectly packaged. The product was distributed to wholesalers in Pennsylvania and New York.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to incorrect packaging, which is a packaging-only problem with no reported injuries or illnesses, fitting the 'Low' severity criteria.
Plain-English summary
Septodont is recalling 24 units of Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing dental adhesive. The recall was initiated because the material was incorrectly packaged. The product is used to adhere restorative material to the tooth during dental restorations. Each package contains 100 unit dose tips, 100 applicator brushes, and a product insert.
The affected product is identified by Product Order Number 950-9119, Lot Number C4211-3, and UPC Code *950-9119*. The expiration date for the recalled units is September 2015. The product was distributed to two wholesalers in Pennsylvania and New York. No product was distributed outside of the United States or to government or VA consignees.
Dental professionals who have purchased this specific lot should stop using the product and contact the recalling firm for instructions on return or disposal. Consumers are not directly affected as this is a professional dental product.
The recalled product
- 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.
- Manufacturer
- Novocol, Inc.
- Category
- Medical Device — Dental Adhesive
- Hazard
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Product Order Number 950-9119
- Lot Number C4211-3
- UPC Code *950-9119*
- Expiration Date September 2015.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Novocol, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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See all →- LowSeptodont Recalls Self-Etch Bond Adhesive Due to Packaging Error
FDA (Devices) · 2014-08-06
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