BEUDAMED
    FDA Enforcement Class II Terminated

    Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.

    Recall: Z-1788-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1788-2014
    Event ID
    68426
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kerr Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2014
    Initiation Date
    May 29, 2014
    Classification Date
    June 13, 2014
    Termination Date
    October 27, 2014
    Address
    28200 Wick Rd, N/A, Romulus, MI, 48174-2639, United States

    Description

    Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.

    Reason

    Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use.

    Code Info

    Part Number 29948, Lot Number 3-1294. Expires October 2016

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, Australia, Belgium, Czech Republic, Germany, Spain, France, Great Britain, French Guiana, Italy, Portugal, and Saudi Arabia.

    Quantity

    2,030 units