BEUDAMED
    FDA Recall 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 · Initiated March 11, 2013

    Recall

    Recall Number
    Z-0973-2013
    Event Number
    64633
    Firm
    Keystone Dental Inc
    FEI Number
    3005990499
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 11, 2013
    Posted
    March 20, 2013
    Terminated
    September 26, 2013
    Address
    144 Middlesex Tpke, Burlington, MA, 01803-4403

    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

    Action

    Keystone Dental initially called customers on 3/11/13 and forms were completed to document these calls. In addition, a letter sent via Federal Express/or hand delivered to all distributors and customers. Product requested to be returned.

    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