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U.S. Department of Health and Human Services

Class 2 Device Recall Bosworth Copalioner

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 Class 2 Device Recall Bosworth Copalionersee related information
Date Initiated by FirmJuly 21, 2023
Date PostedSeptember 12, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2579-2023
Recall Event ID 92851
510(K)NumberK933505 
Product Classification Varnish, cavity - Product Code LBH
ProductKeystone 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
Code Information UDI: *+H66809215261/$$3241027NB7972%* Lot No. NB7972
Recalling Firm/
Manufacturer		 Keystone Industries
480 S Democrat Rd
Gibbstown NJ 08027-1239
For Additional Information ContactSAME
856-663-4700
Manufacturer 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).
FDA Determined
Cause 2		Process control
ActionKeystone 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 in Commerce337 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LBH
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