Keystone Industries: Medical Device Recall in 2023 - (Recall #: Z-2580-2023)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2023.
Data Source: FDA.
Product Description:
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Product Classification:
Class II
Date Initiated: April 10, 2023
Date Posted: September 20, 2023
Recall Number: Z-2580-2023
Event ID: 92856
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
Status: Ongoing
Product Quantity: 240 units
Code Information:
UDI: +H65857007171/$$325120723B058BP Lot Number: 23B058B
Distribution Pattern:
US Nationwide distribution in the states of IL, PA, FL NV, TX.
Voluntary or Mandated:
Voluntary: Firm initiated