BEUDAMED
    FDA Enforcement Class II Ongoing

    Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718

    Recall: Z-2580-2023 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2580-2023
    Event ID
    92856
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Keystone Industries
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 20, 2023
    Initiation Date
    April 10, 2023
    Classification Date
    September 12, 2023
    Address
    480 S Democrat Rd, Gibbstown, NJ, 08027-1239, United States

    Description

    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

    Code Info

    UDI: +H65857007171/$$325120723B058BP Lot Number: 23B058B

    Distribution

    US Nationwide distribution in the states of IL, PA, FL NV, TX.

    Quantity

    240 units