Recall Z-2579-2023 ยท LBH Varnish, Cavity
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
| Date | Sep 12, 2023 (initiated Jul 21, 2023) |
| Status | Open, Classified |
| 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 |
| Quantity | 337 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933505 | BOSWORTH COPALIONER Harry J. Bosworth Co., Jan 7, 1994 |