BEUDAMED
    FDA Recall 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 · Initiated June 16, 2017

    Recall

    Recall Number
    Z-0718-2018
    Event Number
    79066
    Firm
    Keystone Dental Inc
    FEI Number
    3005990499
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    June 16, 2017
    Terminated
    April 16, 2019
    Address
    154 Middlesex Tpke, Burlington, MA, 01803-4403

    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.

    Action

    Consignees were initially called between June 13, 2017 and June 20, 2017. Customer Relations Fax Back forms were completed to document the phone calls. A notification letter was also sent via FedEx or hand-delivered on 6/19/17. All returned product will be scrapped. For further questions, please call (781) 328-3313.

    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