BEUDAMED
    FDA Recall Terminated

    Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K

    Recall: Z-1818-2017 · Initiated March 9, 2017

    Recall

    Recall Number
    Z-1818-2017
    Event Number
    76782
    Firm
    Keystone Dental Inc
    FEI Number
    3005990499
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 9, 2017
    Posted
    April 13, 2017
    Terminated
    July 5, 2017
    Address
    154 Middlesex Tpke, Burlington, MA, 01803-4403

    Description

    Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K

    Reason

    Straight PrimaConnex Implants contained Tapered PrimaConnex Implants

    Action

    Keystone Dental initiated a market removal communication by telephone to customers on 3/9/2017. Customer Relations Fax Back Forms were completed to document these calls. In addition, a letter was sent via Federal Express/or hand delivered to all distributors and customers on 3/13/2017. Product returns requested and if implanted to implement healing and prosthetic protocol. Toll Free: 866-902-9272

    Distribution

    CA, IL, IN, FL, MA, MN, NJ, NV, PA,

    Quantity

    59 units