NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surg...
FDA Device Recall #Z-0372-2023 — Class II — October 27, 2022
Recall Summary
| Recall Number | Z-0372-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 27, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medacta Usa Inc |
| Location | Memphis, TN |
| Product Type | Devices |
| Quantity | 14 units |
Product 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 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.
Distribution Pattern
AL, FL, NH, CO, IL, SC, AR
Lot / Code Information
Document Reference Code 99.81NEXTAR.12US (for US market only), Revision Numbers: Rev.02 and previous
Other Recalls from Medacta Usa Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1401-2023 | Class II | MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03... | Mar 8, 2023 |
| Z-1405-2023 | Class II | MectaLIF ANTERIOR - Antibackout Lag Cover, REF ... | Mar 8, 2023 |
| Z-1404-2023 | Class II | MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03... | Mar 8, 2023 |
| Z-1402-2023 | Class II | MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03... | Mar 8, 2023 |
| Z-1403-2023 | Class II | MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03... | Mar 8, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.