Recall Z-2580-2023 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
Keystone Industries
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
| Date | Sep 12, 2023 (initiated Apr 10, 2023) |
| Status | Open, Classified |
| Reason | 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 |
| Root 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 |
| Quantity | 240 units |
| Distribution | US Nationwide distribution in the states of IL, PA, FL NV, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.