TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Thr...
FDA Device Recall #Z-1791-2024 — Class II — March 19, 2024
Recall Summary
| Recall Number | Z-1791-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 19, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | TriMed Inc. |
| Location | Santa Clarita, CA |
| Product Type | Devices |
| Quantity | 142 units |
Product Description
TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only
Reason for Recall
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
Distribution Pattern
US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IL, LA, MA, MI, NC, NJ, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI.
Lot / Code Information
UDI: 00842188127878/ Lot # QM23086
Other Recalls from TriMed Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1792-2024 | Class II | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: ... | Mar 19, 2024 |
| Z-0932-2024 | Class II | Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL... | Nov 28, 2023 |
| Z-1101-2023 | Class II | RipCord Syndesmosis Button, REF: STA001K | Dec 22, 2022 |
| Z-0359-2020 | Class II | TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WH... | Sep 28, 2018 |
| Z-0357-2020 | Class II | TriMed Hex Driver 1.2, 55mm AO Cannulated, REF ... | Sep 28, 2018 |
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.