BEUDAMED
    FDA Recall 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 · Initiated September 15, 2016

    Recall

    Recall Number
    Z-0299-2017
    Event Number
    75224
    Firm
    Keystone Dental Inc
    FEI Number
    3005990499
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 15, 2016
    Posted
    October 21, 2016
    Terminated
    January 3, 2017
    Address
    154 Middlesex Tpke, Burlington, MA, 01803-4403

    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)

    Action

    Keystone Dental initially called all customers on September 15, 2016. Forms were completed to document these calls. In addition a letter has been sent via Federal Express/or hand delivered on September 19, 2016, to all distributors and customers. Customers with questions were instructed to contact Customer Relations. For questions regarding this recall call 781-328-3390.

    Distribution

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

    Quantity

    55 units