BEUDAMED
    FDA Recall 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 · Initiated October 27, 2022

    Recall

    Recall Number
    Z-0372-2023
    Event Number
    91091
    Firm
    Medacta Usa Inc
    FEI Number
    3006639916
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 27, 2022
    Posted
    December 3, 2022
    Terminated
    October 23, 2023
    Address
    3973 Delp St, Memphis, TN, 38118-6110

    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.

    Action

    Medacta issued an URGENT - Field Safety Notice to the surgeons on 10/28/2022 by email The notice provided the following information: "1. Description of advisory: The following 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. The updated Surgical Technique is attached to this document and can be found at: resources.medacta.com. 2. Action to take: - Transmit this communication all end-users, ensuring it is fully understood. - Verify acknowledgment through end-user signature on the attached receipt. - Return all the signed receipts to the Regulatory Department of Medacta International. 3. Contact person and return address: Stefano Baj, Regulatory Affairs Director Medacta International SA, Strada Regina, CH-6847 Castel San Pietro, Switzerland Tel: +41 (0)91 696 60 60, Fax: +41 (0)91 696 60 66"

    Distribution

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

    Quantity

    14 units