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Recall Observatory FDA recall evidence

Device product

TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances

Z-2093-2025

January 19, 2024

Class III

Product summary

Firm
STRATASYS LTD
Event
Event 97021
Status
Completed
Classification
Class III
Quantity
68
Official record key
device-enforcement:Z-2093-2025

Official wording

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 information: UDI-DI 7290018915806 Lot 22861 (exp. 01-Feb-2024)

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.