Z-2580-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2023
- Initiation Date
- April 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240 units
Product Description
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
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
Distribution Pattern
US Nationwide distribution in the states of IL, PA, FL NV, TX.
Code Information
UDI: +H65857007171/$$325120723B058BP Lot Number: 23B058B