BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2259-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2259-2013
    Event ID
    66276
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2013
    Initiation Date
    September 13, 2013
    Classification Date
    September 19, 2013
    Termination Date
    February 11, 2014
    Address
    1717 W Collins Ave, N/A, Orange, CA, 92867-5422, United States

    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.

    Code Info

    Part Number 33660. Syringe Lot Number 4580333. Autobag Lot Number 4584609.

    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