BEUDAMED
    FDA Enforcement Class II Terminated

    Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.

    Recall: Z-0718-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0718-2018
    Event ID
    79066
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Keystone Dental Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 7, 2018
    Initiation Date
    June 16, 2017
    Classification Date
    February 26, 2018
    Termination Date
    April 16, 2019
    Address
    154 Middlesex Tpke, N/A, Burlington, MA, 01803-4403, United States

    Description

    Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.

    Reason

    An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.

    Code Info

    Catalog Number D-TAP-MAX7-7, Lot 31444

    Distribution

    USA (nationwide) Distribution to the states of : CA, CO, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to Canada

    Quantity

    72