BEUDAMED
    FDA Recall Open, Classified

    LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;

    Recall: Z-2037-2023 · Initiated May 2, 2023

    Recall

    Recall Number
    Z-2037-2023
    Event Number
    92415
    Firm
    Implant Direct Sybron Manufacturing LLC
    FEI Number
    3001617766
    Product Code
    NHA
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    May 2, 2023
    Posted
    June 29, 2023
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171

    Description

    LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;

    Reason

    Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

    Action

    On 5/2/23, correction notices were emailed to customers who were asked to do the following: 1) Contact recalling firm to arrange return of affected product that has not yet been placed in the patient. 2) Share this notice with those who need to be aware within your organization and any organization where the potentially affected devices have been transferred. 3) Complete and return the acknowledgement form to Questions, complaints, or adverse events can be reported to the recalling firm via phone 1-888-649-6425 (Monday - Friday, 5AM - 5PM PST) or through their website: https://www.implantdirect.com/en-us

    Distribution

    US Nationwide distribution in the states of FL, ID, TX, CA.

    Quantity

    29