STRATASYS LTD recalls TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental…

Recall date

January 19, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2090-2025

FDA classification

Class III

Brand / firm

STRATASYS LTD

Sold / distributed

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.

Why it was 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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances