TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Reported: July 16, 2025 Initiated: January 19, 2024 #Z-2090-2025
Product Description
TrueDent Clear, TDM 100, Model No. OBJ-09164 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.
Details
- Recalling Firm
- STRATASYS LTD
- Units Affected
- 78
- 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.
- Location
- Rehovot, N/A
Frequently Asked Questions
What product was recalled? ▼
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances. Recalled by STRATASYS LTD. Units affected: 78.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 16, 2025. Severity: Low. Recall number: Z-2090-2025.
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