Dental resin cartridges recalled due to expiration date formatting error
STRATASYS TrueDent Magenta dental resin cartridges are being recalled due to an expiration date formatting error that may allow expired resin to be used without system prevention, affecting 94 units nationwide.
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: This is an FDA Class III recall involving a formatting error in expiration date labeling. No illnesses or injuries have been reported. The hazard is theoretical—potential use of expired dental resin due to system failure to recognize expiration. Class III recalls are typically assigned scores of 1 or 2 per the severity rubric.
Plain-English summary
STRATASYS LTD is recalling TrueDent Magenta (TDM130, Model No. OBJ-09166), a light-curable methacrylate-based resin used in dental appliance fabrication. The recall involves 94 units with US nationwide distribution, including states such as Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah, and Wisconsin.
The recall is due to a formatting error in the expiration date that switches the day and month. This error causes either customers to be unable to use the cartridges, or the system to fail to recognize that the resin has expired and thus fail to prevent use of expired material.
Affected cartridges are identified as Lot 23123 (UDI-DI 7290018915608) with an expiration date of 01-May-2024.
The recalled product
- Product
- TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Manufacturer
- STRATASYS LTD
- Category
- Medical Device — Dental Resin
- Hazard
- expiration-date-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 7290018915608 Lot 23123 (exp. 01-May-2024)
Distribution
Distributed nationwide across the United States.
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