WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intend...
FDA Device Recall #Z-1924-2020 — Class II — April 9, 2020
Recall Summary
| Recall Number | Z-1924-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 9, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Wright Medical Technology Inc |
| Location | Arlington, TN |
| Product Type | Devices |
| Quantity | 22 units |
Product Description
WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Reason for Recall
One lot of INBONE Tibial Trays is missing the plasma coating.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
Lot code 1619947
Other Recalls from Wright Medical Technology Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0393-2022 | Class II | Stryker DARCO Screw, Locking, Ti6A14V, REF DC28... | Dec 3, 2021 |
| Z-0392-2022 | Class II | Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: ... | Dec 3, 2021 |
| Z-0316-2022 | Class II | INBONE Total Ankle System, INBONE POLY INSERT S... | Nov 4, 2021 |
| Z-0315-2022 | Class II | INBONE Total Ankle System, INBONE POLY INSERT S... | Nov 4, 2021 |
| Z-2989-2020 | Class II | EVOLVE STEM 8.5MM Model # 496S085 | Aug 26, 2020 |
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.