TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables...
FDA Device Recall #Z-2093-2025 — Class III — January 19, 2024
Recall Summary
| Recall Number | Z-2093-2025 |
| Classification | Class III — Low risk |
| Date Initiated | January 19, 2024 |
| Status | Completed |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | STRATASYS LTD |
| Location | Rehovot, N/A |
| Product Type | Devices |
| Quantity | 68 |
Product Description
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Reason for Recall
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
Distribution Pattern
US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah, Wisconsin.
Lot / Code Information
UDI-DI 7290018915806 Lot 22861 (exp. 01-Feb-2024)
Other Recalls from STRATASYS LTD
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2090-2025 | Class III | TrueDent Clear, TDM 100, Model No. OBJ-09164 L... | Jan 19, 2024 |
| Z-2091-2025 | Class III | TrueDent Cyan, TDM 120, Model No. OBJ-09165 Li... | Jan 19, 2024 |
| Z-2092-2025 | Class III | TrueDent Magenta, TDM130, Model No. OBJ-09166 ... | Jan 19, 2024 |
| Z-2094-2025 | Class III | TrueDent White, TDM110, Model No. OBJ-09168 Li... | Jan 19, 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.