FDA Medical devices recall ·
TrueDent White, TDM110, Model No recall
- Recall number
- Z-2094-2025
- Date
- (initiated January 19, 2024)
- Company / brand
- Stratasys Ltd
1, Holtzman St, Rehovot, N/A, Israel - Category
- Medical devices › Class III
- Classification
- Class III
- Status
- Completed
- Units affected
- 109
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Arkansas Arizona California Colorado Connecticut Florida Georgia Illinois Indiana Massachusetts Maryland Michigan North Carolina North Dakota Nebraska New York Oklahoma Oregon Utah Wisconsin
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (medical devices), recall Z-2094-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.