Device product
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Z-2580-2023
Product summary
- Event
- Event 92856
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 240 units
- Official record key
device-enforcement:Z-2580-2023
Official wording
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
Code information: UDI: +H65857007171/$$325120723B058BP Lot Number: 23B058B
Distribution pattern: US Nationwide distribution in the states of IL, PA, FL NV, TX.
Derived failure modes
-
Unknown
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