BEUDAMED
    FDA Recall Terminated

    Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.

    Recall: Z-2069-2014 · Initiated June 5, 2014

    Recall

    Recall Number
    Z-2069-2014
    Event Number
    68480
    Firm
    Axcentria Pharmaceuticals, LLC
    FEI Number
    3008062657
    Product Code
    EJK
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    June 5, 2014
    Posted
    July 16, 2014
    Terminated
    November 28, 2016
    Address
    306 Keystone Dr, Unit B, Telford, PA, 18969

    Description

    Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.

    Reason

    One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use.

    Action

    Axcentria Pharmaceuticals sent an urgent medical device recall notice, dated June 5, 2014, was sent to customers and described the product, problem, and actions to be taken. Customers were asked to fill out and return the form included. For questions customers were instructed to call 215-453-5055, ext 317.

    Distribution

    US distribution to NY and CA

    Quantity

    528