FDA Enforcement
Class III
Completed
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Recall: Z-2094-2025
·
Reported July 16, 2025
Enforcement
- Recall Number
- Z-2094-2025
- Event ID
- 97021
- Classification
- Class III
- Status
- Completed
- Product Type
- Devices
- Firm
- STRATASYS LTD
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 16, 2025
- Initiation Date
- January 19, 2024
- Classification Date
- July 7, 2025
- Address
- 1, Holtzman St, N/A, Rehovot, N/A, N/A, Israel
Description
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Reason
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.
Code Info
UDI-DI 7290018915202 Lot 22377 (exp. 12-Oct-2023)
Distribution
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.
Quantity
109