FDAFDA · Food and drugs·Recall number Z-2090-2025
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Published July 16, 2025 · Recall initiated: January 19, 2024
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- STRATASYS LTD
- Distributor
- US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah, Wisconsin.
- Lot
- UDI-DI 7290018915004 Lots 22994 (exp. 02-Apr-2024) and 23425 (exp. 07-Nov-2024)
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- Israel
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