Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
FDA Device Recall #Z-1940-2025 — Class II — May 22, 2025
Recall Summary
| Recall Number | Z-1940-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 22, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker GmbH |
| Location | Selzach |
| Product Type | Devices |
| Quantity | 2 |
Product Description
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
Reason for Recall
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of California and Missouri. The countries of Belgium, Japan, Netherlands.
Lot / Code Information
Catalog Number: 1851-0830S. GTIN: 04546540647184. Batch lot number: K09F17F
Other Recalls from Stryker GmbH
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1914-2025 | Class II | Long Nail, RIGHT Gamma4 10x320mm x 125, compone... | May 28, 2025 |
| Z-1939-2025 | Class II | Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Num... | May 22, 2025 |
| Z-1621-2025 | Class II | Guide Wire with Ruler Tube 3x1000 mm DIA; Catal... | Mar 28, 2025 |
| Z-1620-2025 | Class II | Guide Wire with Ruler Tube 3x800 mm DIA; Catalo... | Mar 28, 2025 |
| Z-2219-2024 | Class II | Stryker Hoffman LRF Wire Tensioner REF 4933-9-1... | May 9, 2024 |
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.