Z-2579-2023Class II

Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the...

Name: Z-2579-2023 Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the...
Creator: Keystone Industries
Published: 2023-07-21
License: https://open.fda.gov/license/

Keystone Industries / initiated 2023-07-21 / Open, Classified / root cause: manufacturing process

FDA source

Keystone Industries began a recall of Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against... on 2023-07-21. FDA classified it as Class II and gives the reason as "A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2579-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-21
Posted: 2023-09-12
Recalling firm: Keystone Industries
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
Product code: LBH Varnish, Cavity
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).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Keystone Industries issued Urgent Medical Device Recall Letter to Distributors and End Users via email on July 21, 2023. Letter states reason for recall, health risk and action to take: Wholesale: IMMEDIATE ACTIONS TO BE TAKEN 1.Review product inventory and quarantine all affected product on hand.2.Implement appropriate control measures to quarantine any shipments which may be in transit.3.Review distribution records and identify all customers who were shipped the affected product lot. (If no products were distributed and all units are accounted for skip step 4 and move to step 5.)4.Send End User Recall Notification provided to you with this notification to all identified customers that received product, instructing them to follow the directions on the letter to return all affected products to Keystone Industries.5.Return all affected products in your inventory to Keystone Industries by requesting a Return Materials Authorization (RMA) number at [email protected]. Complete the attached Acknowledgement of Medical Device Recall Form and return within 5 days of receiving this notice. Email the completed form to [email protected] and [email protected]. End-User: 1. Review product inventory on hand. 2. Complete the attached Recall Acknowledgement Form and return within 5 days of receiving this notice. Email the completed form to [email protected] and [email protected]. 3. Follow instructions on the form to return product and receive credit. If you have any questions after reviewing this notice, please email using the address below or call Gloria Zuclich at 856-663-4700 Ext 7252 between 8:00 am and 5:00 pm EST, Monday through Friday,
Quantity in commerce: 337 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.
Product codes and lots: UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2579-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2579-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-12

Product code LBH

K933505Class IIBosworth CopalionerHarry J. Bosworth Co. / cleared 1994-01-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)