BEUDAMED
    FDA Enforcement Class II Terminated

    Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.

    Recall: Z-0727-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0727-2018
    Event ID
    79110
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Keystone Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    August 25, 2017
    Classification Date
    February 27, 2018
    Termination Date
    April 16, 2019
    Address
    154 Middlesex Tpke, N/A, Burlington, MA, 01803-4403, United States

    Description

    Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.

    Reason

    The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.

    Code Info

    Catalog# S2400K, Lot 34276

    Distribution

    Nationally.

    Quantity

    20