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Recall Observatory FDA recall evidence

Device product

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

Z-2579-2023

July 21, 2023

Class II

Product summary

Firm
Keystone Industries
Event
Event 92851
Status
Ongoing
Classification
Class II
Quantity
337 units
Official record key
device-enforcement:Z-2579-2023

Official wording

Reason: A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).

Code information: UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).