TrueDent Cyan dental resin cartridges carry an expiration date formatting error
TrueDent Cyan dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 100 units are affected.
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 arising from a date formatting error on the product rather than any defect in the resin itself.
Plain-English summary
TrueDent Cyan, TDM 120, model number OBJ-09165, a light-curable methacrylate-based resin used to fabricate dental appliances, UDI-DI 7290018915400, is being recalled. The action covers 100 units.
The stated reason is that customers are unable to use cartridges due to a formatting error in the expiration date which switches the day with the month, or alternatively the system will not recognise that a resin is expired and will not prevent the user from using an expired material. The FDA classified the action as Class III, its least serious classification.
Affected lots are 23485, expiring 08-Nov-2024, and 22904, expiring 09-Feb-2024. Distribution was nationwide in the United States, including Arizona, Arkansas and California.
Dental laboratories should identify affected stock using the UDI-DI and lot numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Manufacturer
- STRATASYS LTD
- Category
- Medical Device — Dental material
- Hazard
- date-format-error
- expiration-date
- labeling
- class-iii
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 7290018915400 Lots 23485 (exp. 08-Nov-2024) and 22904 (exp. 09-Feb-2024)
Distribution
Distributed nationwide across the United States.
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