TrueDent Magenta, TDM130, Model No. OBJ-09166 recallZ-2092-2025 · Stratasys Ltd · initiated Jan 19, 2024
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stratasys Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
The firm initiated the recall to the consignee level on January 15, 2024. Customers were asked to coordinate a cartridge replacement. The reporting of this recall was done by the firm retroactively; the issue was resolved in January 2024.
Recall details
- Recall number
- Z-2092-2025
- Status
- Completed
- Initiated by the company
- Jan 19, 2024
- Posted by the FDA
- Jul 7, 2025
- Recalling firm
- Stratasys Ltd
- Quantity
- 94
- Product code
- EBI
- FDA submissions
- K220771
- Distribution
- 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.
Product description
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Code information (models, lots, serial numbers)
UDI-DI 7290018915608 Lot 23123 (exp. 01-May-2024)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TrueDent TrueDent MagentaStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall2 reports
Other devices under the same FDA submission
4 devices cleared under K220771 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- TrueDent TrueDent YellowStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall13 reports
- TrueDent TrueDent ClearStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall4 reports
- TrueDent TrueDent WhiteStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall0 reports
- TrueDent TrueDent CyanStratasys Ltd · Resin, Denture, Relining, Repairing, Rebasing1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97021).
- Z-2090-2025 · CompletedTrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2091-2025 · CompletedTrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2093-2025 · CompletedTrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Z-2094-2025 · CompletedTrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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