BEUDAMED
    FDA Recall Terminated

    NX3 Try-In Gel. The product is used as a tooth shade resin material.

    Recall: Z-2259-2013 · Initiated September 13, 2013

    Recall

    Recall Number
    Z-2259-2013
    Event Number
    66276
    Firm
    Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
    FEI Number
    2024312
    Product Code
    EBF
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    September 13, 2013
    Posted
    September 19, 2013
    Terminated
    February 11, 2014
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    NX3 Try-In Gel. The product is used as a tooth shade resin material.

    Reason

    Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.

    Action

    Kerr Corporation initiated the voluntary recall by sending out notifications on 09/13/2013 via USPS 1st class mail. The recall notification letter, titled "URGENT: MEDICAL DEVICE RECALL", informed customer of the recall's product description, reason for recall, potential risk, instructions to customers and contact information.

    Distribution

    Worldwide Distribution, including Nationwide in the US and the countries of Canada, Great Britain, Australia, France, Germany, Italy, Denmark, Hong Kong, China, Brazil and Saudi Arabia.

    Quantity

    197 units