TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental
Summary
The FDA issued a Class III for TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based r by STRATASYS LTD. 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.
Details
Source
Device Recall
External ID
Z-2093-2025
Action Date
2025-07-16
Status
Completed
Category
device
Product Description
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Lot/Code Info: UDI-DI 7290018915806 Lot 22861 (exp. 01-Feb-2024)
Quantity Affected: 68
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-19
Company
Rehovot, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
STRATASYS LTD has 6 FDA actions in our database, including 5 recalls and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (STRATASYS LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does STRATASYS LTD have FDA actions?
STRATASYS LTD has 6 FDA actions in our database, including 5 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2093-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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