Dental 3D Printer Resin Expiration Date Formatting Error Recalled
STRATASYS recalled 68 cartridges of TrueDent Yellow dental resin (Lot 22861) due to an expiration date formatting error where the day and month are switched. The error prevents system use and may allow expired material application.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall involving a software formatting error that could result in use of expired material. No illnesses or injuries have been reported. The hazard is functional failure and expiration recognition rather than direct patient harm.
Plain-English summary
STRATASYS recalled TrueDent Yellow (TDM140, Model OBJ-09169) dental resin cartridges due to an expiration date formatting error. Affected Lot 22861 (68 cartridges, expiration February 1, 2024) was distributed nationwide across 20 U.S. states.
The expiration date on the cartridges contains a formatting error in which the day and month are reversed. This error prevents customers from using the cartridges in their 3D printing systems. Additionally, the system may not recognize that the resin has expired and may not prevent users from applying expired material in dental appliance fabrication.
Dental professionals and laboratories should immediately discontinue use of affected Lot 22861 cartridges. Contact STRATASYS for replacement cartridges and further guidance.
The recalled product
- Product
- TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Manufacturer
- STRATASYS LTD
- Hazard
- date-formatting-error
- expired-material-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 7290018915806 Lot 22861 (exp. 01-Feb-2024)
Distribution
Distributed nationwide across the United States.
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