FDA recall Z-2091-2025

Product

TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances

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.

Key facts

Status

Completed

Initiation date

2024-01-19

Report date

2025-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rehovot, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2091-2025