TrueDent Cyan (Stratasys) – Expiration Date Error (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Brand
STRATASYS LTD
Lot Codes / Batch Numbers
UDI-DI 7290018915400 Lots 23485 (exp. 08-Nov-2024) and 22904 (exp. 09-Feb-2024)
Products Sold
UDI-DI 7290018915400 Lots 23485 (exp. 08-Nov-2024) and 22904 (exp. 09-Feb-2024)
STRATASYS LTD is recalling TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabr due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026