BEUDAMED
    FDA Enforcement Class II Completed

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    Recall: Z-0790-2020 · Reported January 15, 2020

    Enforcement

    Recall Number
    Z-0790-2020
    Event ID
    84067
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2020
    Initiation Date
    November 28, 2018
    Classification Date
    January 8, 2020
    Address
    3050 E Hillcrest Dr, N/A, Thousand Oaks, CA, 91362, United States

    Description

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    Reason

    The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.

    Code Info

    Lot numbers 104479 and 104963.

    Distribution

    Distribution was made to AL, AZ, CA, FL, GA, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, and VA. There was no government/military distribution. Foreign distribution was made to Canada, Armenia, Australia, Denmark, France, Germany, Great Britain, Iceland, Italy, Lithuania, Netherlands, Poland, Spain, Sweden, and Switzerland.

    Quantity

    274 devices