TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly p...
FDA Device Recall #Z-0118-2020 — Class II — August 24, 2018
Recall Summary
| Recall Number | Z-0118-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 24, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | TriMed Inc. |
| Location | Santa Clarita, CA |
| Product Type | Devices |
| Quantity | 5 devices |
Product Description
TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.
Reason for Recall
Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.
Distribution Pattern
Distribution was made to CA, FL, MD, TX, and WA. There was military and foreign distribution was made to Australia. There was no government distribution.
Lot / Code Information
Lot numbers 28884, 28885, 28886, and 28887
Other Recalls from TriMed Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1791-2024 | Class II | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: ... | Mar 19, 2024 |
| 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-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.