CLASS II ONGOING Device recall · Reported 20 Sep 2023 · FDA Enforcement Report
Keystone Bosworth Copaliner Cavity Varnish .- Intended recalled
Keystone Industries is recalling Keystone Bosworth Copaliner Cavity Varnish .- Intended to provide a marginal seal between, distributed nationwide in the US. The recall was initiated on 21 Jul 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2579-2023
- FDA event ID
- 92851
- Recalling firm
- Keystone Industries, Gibbstown, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jul 2023
- FDA classified
- 12 Sep 2023
- Reported
- 20 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 21 Jul 2023 | Recall initiated by company | |
| 12 Sep 2023 | Classified by FDA | +53 days |
| 20 Sep 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.
Questions about this recall
Why was it recalled?
A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).
Which lots are affected?
UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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