BEUDAMED
    FDA Recall 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 · Initiated March 18, 2022

    Recall

    Recall Number
    Z-1100-2022
    Event Number
    90031
    Firm
    Clinician's Choice Dental Products Inc.
    FEI Number
    2018957
    Product Code
    ELW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 18, 2022
    Terminated
    March 19, 2024
    Address
    559 Federal Rd, Unit B, Brookfield, CT, 06804-2017

    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

    Action

    Clinicians Choice Dental Products Inc issued Urgent Product Recall Letter on 3/22/22 to the US Distributor. Please contact all Customers who purchased the aforementioned LOT after November 12, 2021 and inform them IMMEDIATELY to stop using the product and return it to Henry Schein. Additionally, please examine your inventory to determine if you have any of the aforementioned product(s) in stock. Please discontinue sale IMMEDIATELY and return the entire stock of the denoted lot number to Clinician's Choice. Lastly, please complete the provided Form F-011A - Product Recall Record and return to [email protected]. Should you require any further information, please contact the undersigned at 1-800-265-3444 x 292

    Distribution

    Distributed in SC.

    Quantity

    46 units