STRATASYS LTD recalls TrueDent Yellow
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliancesUDIUDI-DI 7290018915806Affected lot22861
What the firm is doing
The firm initiated the recall to the consignee level on January 15, 2024. Customers were asked to coordinate a cartridge replacement. The reporting of this recall was done by the firm retroactively; the issue was resolved in January 2024.
DistributionShow detailsHide
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.
Use of the product is not likely to cause adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2093-2025
- FDA 510(k) clearance · K220771The device's official FDA premarket clearance record
- FDA device classification · EBIOfficial FDA classification for this device type
- CFR regulation · 21 CFR 872.3760The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find STRATASYS LTDSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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