BEUDAMED
    FDA Enforcement Class II Terminated

    Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912

    Recall: Z-1100-2022 · Reported May 25, 2022

    Enforcement

    Recall Number
    Z-1100-2022
    Event ID
    90031
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clinician's Choice Dental Products Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    May 25, 2022
    Initiation Date
    March 18, 2022
    Classification Date
    May 17, 2022
    Termination Date
    March 19, 2024
    Address
    559 Federal Rd Unit B, N/A, Brookfield, CT, 06804-2017, United States

    Description

    Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912

    Reason

    Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK

    Code Info

    LOT No.: 611612 (UDI): 07540172000178

    Distribution

    Distributed in SC.

    Quantity

    46 units