BEUDAMED
    FDA Enforcement Class II Terminated

    Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework

    Recall: Z-0299-2017 · Reported November 2, 2016

    Enforcement

    Recall Number
    Z-0299-2017
    Event ID
    75224
    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
    November 2, 2016
    Initiation Date
    September 15, 2016
    Classification Date
    October 21, 2016
    Termination Date
    January 3, 2017
    Address
    154 Middlesex Tpke, Burlington, MA, 01803-4403, United States

    Description

    Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework

    Reason

    Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)

    Code Info

    Lot # 27714

    Distribution

    Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy

    Quantity

    55 units