BEUDAMED
    FDA Enforcement Class II Terminated

    NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid

    Recall: Z-0372-2023 · Reported December 14, 2022

    Enforcement

    Recall Number
    Z-0372-2023
    Event ID
    91091
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medacta Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 14, 2022
    Initiation Date
    October 27, 2022
    Classification Date
    December 2, 2022
    Termination Date
    October 23, 2023
    Address
    3973 Delp St, N/A, Memphis, TN, 38118-6110, United States

    Description

    NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid

    Reason

    A warning has been added to the Surgical Technique for NextAR Shoulder, advising verification of suitable patient conditions prior to placement of the NextAR Shoulder Target Holder: WARNING Target fixation requires adequate coracoid bone stability. Osteoporosis, weakness of the coracoid process, or other deficiencies, could lead to adverse events including bone fracture. Verify that the coracoid bone and relevant patient conditions are suitable before proceeding.

    Code Info

    Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous

    Distribution

    AL, FL, NH, CO, IL, SC, AR

    Quantity

    14 units