TrueDent Yellow dental resin cartridges carry an expiration date formatting error
TrueDent Yellow dental resin cartridges are being recalled because a formatting error switches the day and month in the expiration date. 68 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 Yellow, TDM140, model number OBJ-09169, a light-curable methacrylate-based resin used to fabricate dental appliances, UDI-DI 7290018915806, is being recalled. The action covers 68 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.
The affected lot is 22861, expiring 01-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 number above and follow the instructions issued by the manufacturer.
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
- 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 7290018915806 Lot 22861 (exp. 01-Feb-2024)
Distribution
Distributed nationwide across the United States.
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