Z-0372-2023Class II

NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical...

Name: Z-0372-2023 NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical...
Creator: Medacta Usa Inc
Published: 2022-10-27
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2022-10-27 / Terminated

FDA source

Medacta Usa Inc began a recall of NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder... on 2022-10-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0372-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-27
Posted: 2022-12-03
Terminated: 2023-10-23
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
Product code: OLO Orthopedic Stereotaxic Instrument
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 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 in commerce: 14 units
Distribution: AL, FL, NH, CO, IL, SC, AR
Product codes and lots: Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0372-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0372-2023	Class II	Terminated	Voluntary: Firm initiated	2022-12-14	2022-12-02

Product code OLO

K210153Class IINextAR RSA PlatformMedacta International S.A. / cleared 2021-05-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)