BEUDAMED
    FDA Enforcement Class II Terminated

    INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.

    Recall: Z-1835-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1835-2017
    Event ID
    76604
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ace Surgical Supply Co., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2017
    Initiation Date
    February 22, 2017
    Classification Date
    April 17, 2017
    Termination Date
    August 7, 2017
    Address
    1034 Pearl St, N/A, Brockton, MA, 02301-5411, United States

    Description

    INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.

    Reason

    Incorrect device was packaged.

    Code Info

    Lot Number: 16100050

    Distribution

    Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.

    Quantity

    87