BEUDAMED
    FDA Enforcement Class II Ongoing

    ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,

    Recall: Z-0197-2022 · Reported November 10, 2021

    Enforcement

    Recall Number
    Z-0197-2022
    Event ID
    88859
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 10, 2021
    Initiation Date
    September 23, 2021
    Classification Date
    November 3, 2021
    Address
    3050 E Hillcrest Dr, N/A, Westlake Village, CA, 91362-3171, United States

    Description

    ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,

    Reason

    Packaged dental implant contains a different size then the size declared on the labeling.

    Code Info

    lot # 166297 / UDI: 10841307101789

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.

    Quantity

    61 implants