Keystone Industries is recalling 337 units of Keystone Bosworth Copaliner Cavity Varnish (.5oz / 14 ml) because a bottle of Copaliner Solvent was mistakenly packaged inside boxes labeled as Varnish. This product is a dental device intended to provide a seal between dentin and amalgam during dental procedures to protect the tooth. Because the solvent is not the intended varnish, using the incorrectly packaged product could lead to ineffective sealing and potential dental complications. Consumers should verify their supply and contact their healthcare provider or the manufacturer for guidance.
The incorrect packaging of solvent instead of varnish prevents the product from performing its intended function of creating a protective seal for the tooth's dentin. This failure can allow amalgam to penetrate the dentin, potentially leading to tooth sensitivity, secondary decay, or other dental injury.
Healthcare provider or manufacturer contact
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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