FDAJanuary 19, 2024device
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Completed
Brands named
stratasys
UPCs
7290018915400
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDATrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances2024-01-19
- FDATrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances2024-01-19
- FDATrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances2024-01-19
- FDATrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances2024-01-19
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