Dental resin cartridges recalled for expiration date formatting error
Stratasys is recalling TrueDent Cyan dental resin cartridges due to a formatting error in the expiration date that switches the day with the month, and the system may not prevent use of expired material.
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 a Class III recall involving a labeling error in the expiration date format that could result in use of expired material. No illnesses or injuries have been reported. Per the FDA severity rubric, minor labeling errors qualify as Moderate (score 2).
Plain-English summary
Stratasys LTD is recalling TrueDent Cyan, TDM 120 (Model No. OBJ-09165), a light-curable methacrylate-based resin used to fabricate dental appliances.
The cartridges in this recall contain a formatting error in the expiration date that switches the day with the month, making the date unreadable or unrecognizable. Additionally, the system may fail to recognize when a resin cartridge has expired and will not prevent users from using expired material.
The recall includes approximately 100 cartridges distributed nationwide to locations in 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 affected lots are 23485 (original expiration 08-Nov-2024) and 22904 (original expiration 09-Feb-2024).
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 Resin
- Hazard
- mis-labeling
- expired-material
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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