BEUDAMED
    FDA Enforcement Class II Terminated

    Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: 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-0608-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0608-2018
    Event ID
    79040
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Keystone Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 21, 2018
    Initiation Date
    June 20, 2017
    Classification Date
    February 13, 2018
    Termination Date
    April 9, 2018
    Address
    154 Middlesex Tpke, Burlington, MA, 01803-4403, United States

    Description

    Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: 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

    Abutments are unable to accept the final abutment screw

    Code Info

    REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022

    Distribution

    US Nationwide Distribution in the states of ND, NJ & MA

    Quantity

    20 units