BEUDAMED
    FDA Enforcement Class II Ongoing

    Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

    Recall: Z-3209-2018 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-3209-2018
    Event ID
    80763
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2018
    Initiation Date
    May 8, 2018
    Classification Date
    September 20, 2018
    Address
    2320 NW 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

    Reason

    Potentially have non-conforming internal threads.

    Code Info

    Catalog #: 02-012-60-2216 Serial Number: 5370045

    Distribution

    US Distribution to Ohio only.

    Quantity

    1