BEUDAMED
    FDA Enforcement Class II Terminated

    Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.

    Recall: Z-0089-2019 · Reported October 17, 2018

    Enforcement

    Recall Number
    Z-0089-2019
    Event ID
    80297
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2018
    Initiation Date
    May 29, 2018
    Classification Date
    October 9, 2018
    Termination Date
    July 29, 2020
    Address
    3050 E Hillcrest Dr, Thousand Oaks, CA, 91362, United States

    Description

    Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.

    Reason

    Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.

    Code Info

    Part number 8735-05, Lot number 90212

    Distribution

    Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.

    Quantity

    217 units