BEUDAMED
    FDA Recall Terminated

    GoDirect Screw-Retaining Top Part Numbers: 4500-61

    Recall: Z-0961-2017 · Initiated November 28, 2016

    Recall

    Recall Number
    Z-0961-2017
    Event Number
    75838
    Firm
    Implant Direct Sybron Manufacturing, LLC
    FEI Number
    3001617766
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 28, 2016
    Posted
    January 9, 2017
    Terminated
    February 16, 2017
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171

    Description

    GoDirect Screw-Retaining Top Part Numbers: 4500-61

    Reason

    Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

    Action

    On 11/28/16 customers were called and instructed to return the product.

    Distribution

    U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.

    Quantity

    14