Recall Z-2579-2023— Keystone Industries

Name: FDA recall Z-2579-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-21

Class II · Ongoing

Class II FDA medical device recall by Keystone Industries, initiated 2023-07-21. It names one FDA 510(k) clearance: K933505. 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. Reason: A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526)..

Recalling firm: Keystone Industries
Classification: Class II
Status: Ongoing
Initiated: 2023-07-21
Firm location: Gibbstown, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K933505 — BOSWORTH COPALIONERHarry J. Bosworth Co.·cleared 1994-01-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.