Z-2580-2023Class II

Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No...

Name: Z-2580-2023 Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No...
Creator: Keystone Industries
Published: 2023-04-10
License: https://open.fda.gov/license/

Keystone Industries / initiated 2023-04-10 / Open, Classified / root cause: packaging

FDA source

Keystone Industries began a recall of Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718 on 2023-04-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2580-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-10
Posted: 2023-09-12
Recalling firm: Keystone Industries
Product: Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Product code: EBI Resin, Denture, Relining, Repairing, Rebasing
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
Root cause tag: packaging
FDA 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 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.
Product codes and lots: UDI: +H65857007171/$$325120723B058BP Lot Number: 23B058B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2580-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2580-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-20	2023-09-12

Product code EBI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)