CLASS II ONGOING Device recall · Reported 20 Sep 2023 · FDA Enforcement Report
Henry Schein Hard Line Chairside Reline kit-Resilient recalled
Keystone Industries is recalling Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI, distributed nationwide in the US. The recall was initiated on 10 Apr 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2580-2023
- FDA event ID
- 92856
- Recalling firm
- Keystone Industries, Gibbstown, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Apr 2023
- FDA classified
- 12 Sep 2023
- Reported
- 20 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 10 Apr 2023 | Recall initiated by company | |
| 12 Sep 2023 | Classified by FDA | +155 days |
| 20 Sep 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Where it was distributed
US Nationwide distribution in the states of IL, PA, FL NV, TX.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
UDI: +H65857007171/$$325120723B058BP Lot Number: 23B058B
Where was it sold?
US Nationwide distribution in the states of IL, PA, FL NV, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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