BEUDAMED
    FDA Enforcement Class II Terminated

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    Recall: Z-0847-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0847-2014
    Event ID
    67207
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 5, 2014
    Initiation Date
    January 6, 2014
    Classification Date
    January 28, 2014
    Termination Date
    July 7, 2014
    Address
    1900 Aston Ave, Carlsbad, CA, 92008-7308, United States

    Description

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    Reason

    Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state ¿3.7 x 10mm instead of ¿4.7 x 11.5mm.

    Code Info

    Catalog Number TSVWB11, Lot 62470008.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Thailand, Japan, Hong Kong, Morocco, and UAE.

    Quantity

    307