Z-2091-2025 Class III
Recall Details
- Product Type
- Devices
- Report Date
- July 16, 2025
- Initiation Date
- January 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100
Product Description
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Reason for Recall
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.
Distribution Pattern
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.
Code Information
UDI-DI 7290018915400 Lots 23485 (exp. 08-Nov-2024) and 22904 (exp. 09-Feb-2024)