Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Recall
- Recall Number
- Z-2580-2023
- Event Number
- 92856
- Firm
- Keystone Industries
- FEI Number
- 3010002722
- Product Code
- EBI
- Status
- Open, Classified
- Root Cause
- Packaging process control
- Initiated
- April 10, 2023
- Posted
- September 12, 2023
- Address
- 480 S Democrat Rd, Gibbstown, NJ, 08027-1239
Description
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
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
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
US Nationwide distribution in the states of IL, PA, FL NV, TX.
240 units