Medacta Usa Inc: 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 number

Z-0372-2023

Recalling firm

Medacta Usa Inc

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

Status

Terminated

Initiated

2022-10-27

Posted

2022-12-03

Terminated

2023-10-23

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.

Root 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

14 units

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K210153"]

PMA numbers

not on file

Product code

OLO

Firm FEI

3006639916

Firm city

Memphis

Firm state

TN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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