BEUDAMED
    FDA Recall Terminated

    DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F

    Recall: Z-2436-2019 · Initiated July 19, 2019

    Recall

    Recall Number
    Z-2436-2019
    Event Number
    83396
    Firm
    Coltene Whaledent AG Feldwiesenstrasse 20 Altstatten Sg Switzerland
    FEI Number
    3002806620
    Product Code
    EJL
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    July 19, 2019
    Terminated
    April 30, 2021

    Description

    DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F

    Reason

    A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length.

    Action

    The firm initiated the recall by email on 07/19/2019 requesting that the consignee return any unused product for replacement.

    Distribution

    GA

    Quantity

    20 units of 5 burs/unit