Class 2 Device Recall Medacta NextAR

• Date Initiated by Firm: October 27, 2022
• Date Posted: December 03, 2022
• Recall Status: Terminated on October 23, 2023
• Recall Number: Z-0372-2023
• Recall Event ID: 91091
• 510(K)Number: K210153
• Product Classification: Orthopedic stereotaxic instrument - Product Code OLO
• Product: 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
• Code Information: Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous
• Recalling Firm/ Manufacturer: Medacta Usa Inc; 3973 Delp St; Memphis TN 38118-6110
• For Additional Information Contact: Customer Service ; 866-830-1063
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• 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"
• Quantity in Commerce: 14 units
• Distribution: AL, FL, NH, CO, IL, SC, AR
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OLO