BEUDAMED
    FDA Enforcement Class II Ongoing

    Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.

    Recall: Z-2050-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-2050-2023
    Event ID
    92414
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2023
    Initiation Date
    June 5, 2023
    Classification Date
    June 30, 2023
    Address
    2320 Nw 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.

    Reason

    The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

    Code Info

    Catalog #531-07-05 - Lot numbers: 154287001, 295878002, and 302331004; UDI-DI 10885862542038.

    Distribution

    Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NV, NY, OH, OK, PA, SC, TN, TX, WI, as well as PR. There was no government/military distribution. Foreign distribution was made to Australia, France, and Japan.

    Quantity

    250 devices