Class 2 Device Recall Henry Schein

• Date Initiated by Firm: April 10, 2023
• Date Posted: September 12, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2580-2023
• Recall Event ID: 92856
• Product Classification: Resin, denture, relining, repairing, rebasing - Product Code EBI
• Product: Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
• Code Information: UDI: +H65857007171/$$325120723B058BP Lot Number: 23B058B
• Recalling Firm/ Manufacturer: Keystone Industries; 480 S Democrat Rd; Gibbstown NJ 08027-1239
• For Additional Information Contact: SAME; 856-663-4700
• Manufacturer Reason for Recall: The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials
• FDA Determined Cause: Packaging process control
• Action: Keystone Industries notified the wholesaler on 4/10/23 via via email to initiate a warehouse alert and hold further shipments. A follow-up Letter was sent to the Wholesaler by email on April 12, 2023, with instructions for conducting the recall. The Wholesaler in turn sent a Recall Notification to all end user facilities on April 13, 2023. Letter states reason for recall, health risk and action to take: 1. Contact the appropriate warehouses identified above and issue an alert to stop all shipments of the affected product. 2. Have each warehouse check their inventory to determine if any of the affected product remains in their stock and segregate all affected units from inventory for return. 3. Implement appropriate control measures to quarantine any future shipments of the affected product that may be in transit to your warehouses. 4. Review distribution records and trace all affected product kits sent to customers. 5. Send Recall Notification on Henry Schein letterhead to all identified customers that received product, instructing them to return all affected products to your appropriate distribution center. Provide a copy of the Customer Recall Notification Letter template to Keystone Industries for submission to the FDA. 6. Quarantine all product returned from customers until the completion of the recall. Recall should end within 15 working days of issuing the Customer Recall Notifications. 7. Provide Keystone with a final report which records the amount of product returned from each Henry Schein distribution warehouse, amount originally shipped to each customer, number of customers, and number of products returned from each customer. 8. Upon completion of the recall, return all affected products to Keystone Industries by requesting Return Materials Authorization (RMA) number and scheduling product pickup with your appropriate sales representative. Complete the attached Acknowledgement of Medical Device Correction Form and return within 5 days of receiving this
• Quantity in Commerce: 240 units
• Distribution: US Nationwide distribution in the states of IL, PA, FL NV, TX.
• Total Product Life Cycle: TPLC 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.