FDA Device recall Z-0372-2023
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a…
- FDA Device
- Class II
- terminated
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class II recall of NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a… by Medacta Usa, citing 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 Holde….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0372-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-10-27 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medacta Usa |
| Distribution | AL, AR, CO, FL, IL, NH, SC |
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
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.
Identifiers
| code_info | Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0372-2023%22
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