BEUDAMED
    FDA Enforcement Class II Ongoing

    OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM

    Recall: Z-2157-2024 · Reported June 26, 2024

    Enforcement

    Recall Number
    Z-2157-2024
    Event ID
    94409
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 26, 2024
    Initiation Date
    April 18, 2024
    Classification Date
    June 18, 2024
    Address
    2320 Nw 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM

    Reason

    Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

    Code Info

    a) 200-05-23, UDI/DI 10885862039835, Lot Numbers: b) 200-05-26, UDI/DI 10885862039842, Lot Numbers: c) 200-05-29, UDI/DI 10885862039859, Lot Numbers:

    Distribution

    Worldwide distribution.

    Quantity

    N/A