BEUDAMED
    FDA Recall 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 · Initiated May 29, 2018

    Recall

    Recall Number
    Z-0089-2019
    Event Number
    80297
    Firm
    Implant Direct Sybron Manufacturing, LLC
    FEI Number
    3001617766
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 29, 2018
    Terminated
    July 29, 2020
    Address
    3050 E Hillcrest Dr, Thousand Oaks, CA, 91362

    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.

    Action

    On May 29, 2018, Implant Direct Sybron Manufacturing LLC issued URGENT MEDICAL DEVICE RECALL notices to their customers via FedEx overnight mail. Customers were instruction to take the following actions: 1. Review your inventory for the affected product. 2. Complete and return the Acknowledgement Form within 48 hours for the product listed; Quarantine and return impacted product. 3. Authorized Implant Direct Sybron Manufacturing LLC distributors, should identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within48 hours of receipt of the notification. Customers with questions may contact Implant Direct Sybron Manufacturing LLC Customer Care at 888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST.

    Distribution

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

    Quantity

    217 units