BEUDAMED
    FDA Enforcement Class II Terminated

    PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

    Recall: Z-0973-2013 · Reported March 27, 2013

    Enforcement

    Recall Number
    Z-0973-2013
    Event ID
    64633
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Keystone Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 27, 2013
    Initiation Date
    March 11, 2013
    Classification Date
    March 20, 2013
    Termination Date
    September 26, 2013
    Address
    144 Middlesex Tpke, N/A, Burlington, MA, 01803-4403, United States

    Description

    PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

    Reason

    Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled

    Code Info

    Lot Number: 12857

    Distribution

    Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.

    Quantity

    120 units