Z-2579-2023 Class II Ongoing
FDA device recall Z-2579-2023 was initiated by Keystone Industries on July 21, 2023 and is designated Class II. 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). The recall status is ongoing. Affected quantity: 337 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2023
- Initiation Date
- July 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 337 units
Product Description
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
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).
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.
Code Information
UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972