nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300...

FDA Device Recall #Z-1897-2026 — Class II — March 9, 2026

Recall Summary

Recall Number Z-1897-2026
Classification Class II — Moderate risk
Date Initiated March 9, 2026
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm XTANT Medical Holdings, Inc
Location Belgrade, MT
Product Type Devices
Quantity 225

Product Description

nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss 3D Advanced Bone Graft Substitute, 25x100x8mm, 20cc 90-300-25508: nanOss 3D Advanced Bone Graft Substitute, 25x50x8mm, 10cc 90-300-251004: nanOss 3D Advanced Bone Graft Substitute, 25x100x4mm, 10cc 90-400-25508: nanOss 3D Plus Advanced Bone Graft Substitute, 25x50x8mm, 10cc

Reason for Recall

Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

Distribution Pattern

US Nationwide distribution in the states and territories of CA, CT, DC, KS, MD, NC, NY, TX, and WI.

Lot / Code Information

Part #: 90-300-251008 UDI-DI 00849777012478 Lot #(s): 385486-RP25-0080 387070-RP25-0081 415971-RP25-0077 436563-RP25-0082 436564-RP25-0079 436565-RP25-0076 444927-RP25-0078 Part #: 90-300-25508 UDI-DI 00849777012492 Lot #(s): 387071-RP25-0083 418098-RP25-0084 436199-RP25-0085 Part #: 90-300-251004 UDI-DI 00849777012461 Lot #(s): 401347-RP25-0070 415871-RP25-0073 415872-RP25-0074 416678-RP25-0072 416679-RP25-0071 418509-RP25-0075 Part #: 90-400-25508 UDI-DI 00849777012539 Lot #(s): 445442-RP25-0128

Other Recalls from XTANT Medical Holdings, Inc

Recall # Classification Product Date
Z-1773-2026 Class II XTANT MEDICAL Xpress Pedicle Screw System Dual ... Feb 18, 2026
Z-1177-2025 Class II Irix-A Integrated Lumbar Fusion System, Model N... Jan 3, 2025
Z-0125-2025 Class II Cortera Spinal Fixation System Screw, Poly, Sol... Aug 21, 2024
Z-0846-2024 Class II Cortera Spinal Fixation System, REF: 150100-850... Nov 28, 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.