BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1818-2017 · Reported April 19, 2017

    Enforcement

    Recall Number
    Z-1818-2017
    Event ID
    76782
    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
    April 19, 2017
    Initiation Date
    March 9, 2017
    Classification Date
    April 13, 2017
    Termination Date
    July 5, 2017
    Address
    154 Middlesex Tpke, N/A, Burlington, MA, 01803-4403, United States

    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

    Code Info

    Lot Number: 30214

    Distribution

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

    Quantity

    59 units