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

FDA device recall Z-2579-2023 · posted 2023-09-12 · Open, Classified

Recall details

Recalling firm

Keystone Industries

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).

Action taken

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,

Root cause

Process control

Status

Open, Classified

Product code

LBH

Quantity affected

337 units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.

Date initiated

2023-07-21

Date posted

2023-09-12

Location

Gibbstown, NJ

Related 510(k) clearances