TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM ...
FDA Device Recall #Z-1636-2014 — Class II — April 4, 2014
Recall Summary
| Recall Number | Z-1636-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 4, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Smith & Nephew Inc |
| Location | Memphis, TN |
| Product Type | Devices |
| Quantity | 1,253 units total |
Product Description
TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207, 10 MM X 18 CM, 130 degree, (7) REF 71675208, 11.5 MM X 18 CM, 130 degree, (8) REF 71675211, 11.5 MM X 20 CM, 130 degree, Smith & Nephew, Inc. Orthopedic fixation device.
Reason for Recall
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Distribution Pattern
Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
Lot / Code Information
TRIGEN INTERTAN NAIL: (1) REF 71675201, Lot Numbers: 13LT36305, 13LT36306, 13LT36547, 13LT36548, 13LT37009, 13LT37010, 13MT37347, 13MT37665, 13MT37667, 13MT37668, 14AT38179, 14AT38180, 14AT38181, 14T38182, 14AT38183, 14AT38189, 14AT38190 (2) REF 71675202, Lot Numbers: 13LT36308, 13LT36549, 13LT37011, 13MT37348, 14AT38750 (3) REF 71675203, Lot Numbers: 13KT36106, 13LT36596, 14AT38494 (4) REF 71675204, Lot Numbers: 13LT36597, 13LT37012, 14AT38495, 14AT38660 (5) REF 71675205, Lot Number 13LT36598 (6) REF 71675207, Lot Numbers: 13LT363089, 13LT36310, 13LT36599, 13LT37058, 13LT37059, 13LT37063, 13MT37264, 13MT37265, 13MT37266, 13MT37329, 13MT37349, 13MT37350, 13MT37669, 13MT37671, 13MT37672 (7) REF 71675208, Lot Numbers: 13LT36311, 13LT36312, 13LT36600, 13LT37060, 13LT37061, 13MT37351, 13MT37666, 13MT37963 (8) REF 71675211, Lot Number 13LT36313
Other Recalls from Smith & Nephew Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0277-2025 | Class II | smith&nephew LEIGON OXINIUM CONSTRAINED NONPORO... | Oct 2, 2024 |
| Z-0281-2025 | Class II | smith&nephew GENESIS II NONPOROUS POSTERIOR STA... | Oct 2, 2024 |
| Z-0278-2025 | Class II | smith&nephew LEIGON OXINIUM CONSTRAINED NONPORO... | Oct 2, 2024 |
| Z-0282-2025 | Class II | smith&nephew LEGION OXINIUM POSTERIOR STABILIZE... | Oct 2, 2024 |
| Z-1901-2024 | Class II | smith&nephew OXINIUM Femoral Head 12/14 Taper, ... | Apr 24, 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.