Stratasys Ltd is recalling approximately 449 units of TrueDent Dental Resins in Clear, Cyan, Magenta, Yellow, and White variants. These 3D printing resins, used to make dental appliances, contain a formatting error that swaps the day and month of the expiration date. This defect can either prevent users from using valid cartridges or fail to block the use of material that has actually expired. No injuries have been reported to date.
The software system may fail to recognize when the resin is expired, which could lead to the fabrication of dental appliances using material with degraded properties. Conversely, valid cartridges may be incorrectly identified as expired, causing unnecessary work interruptions.
Light-curable methacrylate-based resin
Light-curable methacrylate-based resin
Light-curable methacrylate-based resin
Light-curable methacrylate-based resin
Light-curable methacrylate-based resin
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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