FDA Medical Device Recalls (openFDA)
Keystone Industries: 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
- Recall number
- Z-2579-2023
- 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
- Status
- Open, Classified
- Initiated
- 2023-07-21
- Posted
- 2023-09-12
- Terminated
- not on file
- Reason
- A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).
- 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 credits@keystoneind.com. Complete the attached Acknowledgement of Medical Device Recall Form and return within 5 days of receiving this notice. Email the completed form to amcclure@keystoneind.com and tschwear@keystoneind.com. 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 amcclure@keystoneind.com and tschwear@keystoneind.com. 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
- 337 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.
- Lot, serial or model codes
- UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972
- 510(k) numbers
- ["K933505"]
- PMA numbers
- not on file
- Product code
- LBH
- Firm FEI
- 3010002722
- Firm city
- Gibbstown
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28