FDA Device recall Z-2093-2025
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- FDA Device
- Class III
- completed
- Published 2025-07-16
On 2025-07-16 the FDA classified a Class III recall of TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances by Stratasys, citing 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 ex….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2093-2025 |
| Classification | Class III |
| Status | completed |
| Initiated | 2024-01-19 |
| Published | 2025-07-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stratasys |
| Distribution | US |
Product
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Reason
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.
Identifiers
| code_info | UDI-DI 7290018915806 Lot 22861 (exp. 01-Feb-2024) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2093-2025%22
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