BEUDAMED
    FDA Enforcement Class II Terminated

    The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.

    Recall: Z-0268-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0268-2013
    Event ID
    63297
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kerr Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 14, 2012
    Initiation Date
    February 21, 2012
    Classification Date
    November 8, 2012
    Termination Date
    November 15, 2012
    Address
    28200 Wick Rd, N/A, Romulus, MI, 48174-2639, United States

    Description

    The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.

    Reason

    The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible tooth fracture or tooth extraction.

    Code Info

    ¿Product Part Numbers Lot Number AlgiNot Intra Kit 34683 1-1017 AlgiNot Volume Refills 34682 1-1017

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.

    Quantity

    45 kits and 87 refills