STRATASYS LTD: Medical Device Recall in 2025 - (Recall #: Z-2092-2025)
See the recall detail below. You can also see other recalls from the same firm in 2025.
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Class III
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.
UDI-DI 7290018915608 Lot 23123 (exp. 01-May-2024)
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.
Voluntary: Firm initiated