BEUDAMED
    FDA Enforcement Class II Terminated

    Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

    Recall: Z-2162-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2162-2018
    Event ID
    80112
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Keystone Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    May 1, 2018
    Classification Date
    June 11, 2018
    Termination Date
    September 14, 2018
    Address
    154 Middlesex Tpke, N/A, Burlington, MA, 01803-4403, United States

    Description

    Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

    Reason

    The implants are mislabeled.

    Code Info

    UDI: D76815737K0, Lot 37038

    Distribution

    US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.

    Quantity

    72