BEUDAMED
    FDA Enforcement Class II Terminated

    Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant

    Recall: Z-0363-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0363-2020
    Event ID
    83794
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2019
    Initiation Date
    October 26, 2018
    Classification Date
    November 12, 2019
    Address
    3050 E Hillcrest Dr, N/A, Westlake Village, CA, 91362-3171, United States

    Description

    Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant

    Reason

    packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.

    Code Info

    Lot numbers 120197; Exp. 07/16/2023 and 120198; Exp. 07/19/2023

    Distribution

    US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,

    Quantity

    53 implants