Recall Z-2580-2023— Keystone Industries

Name: FDA recall Z-2580-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-10

Class II · Ongoing

Class II FDA medical device recall by Keystone Industries, initiated 2023-04-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718. 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.

Recalling firm: Keystone Industries
Classification: Class II
Status: Ongoing
Initiated: 2023-04-10
Firm location: Gibbstown, NJ, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.