BEUDAMED
    FDA Recall 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 · Initiated January 6, 2014

    Recall

    Recall Number
    Z-0847-2014
    Event Number
    67207
    Firm
    Zimmer Dental Inc
    FEI Number
    1038806
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    January 6, 2014
    Posted
    January 28, 2014
    Terminated
    July 7, 2014
    Address
    1900 Aston Ave, Carlsbad, CA, 92008-7308

    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.

    Action

    Zimmer Dental initiated the recall on 01/06/2013 by sending out recall notifications via FedEx to domestic customers and via electric mail to international customers. Customers are sent a letter identifying the issue, product description with codes, risk, instructions, and contact information. The letter's instructions include locating the affected product and return unused product to Zimmer Dental and notifying the amount of product that has been consumed.

    Distribution

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

    Quantity

    307