BEUDAMED
    FDA Recall 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 · Initiated February 22, 2017

    Recall

    Recall Number
    Z-1835-2017
    Event Number
    76604
    Firm
    Ace Surgical Supply Co., Inc.
    FEI Number
    1287163
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 22, 2017
    Posted
    April 17, 2017
    Terminated
    August 7, 2017
    Address
    1034 Pearl St, Brockton, MA, 02301-5411

    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.

    Action

    ACE sent a Customer Notice letter dated February 22, 2017 via certified mail to customers. The letter identified the affected product, problem, risk to health and actions to be taken. Customers were instructed to complete and return the enclosed Business Reply Form. For question call 1-800-441-3100 ext. 208.

    Distribution

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

    Quantity

    87