Z-2091-2025Class III

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

Name: Z-2091-2025 TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication...
Creator: Stratasys Ltd
Published: 2024-01-19
License: https://open.fda.gov/license/

Stratasys Inc. / initiated 2024-01-19 / Completed / root cause: software

FDA source

STRATASYS LTD began a recall of TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances on 2024-01-19. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-2091-2025
Classification: Class III
Status: Completed
Initiated: 2024-01-19
Posted: 2025-07-07
Recalling firm: Stratasys Inc.
Product: TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Product code: EBI Resin, Denture, Relining, Repairing, Rebasing
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 100
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.
Product codes and lots: UDI-DI 7290018915400 Lots 23485 (exp. 08-Nov-2024) and 22904 (exp. 09-Feb-2024)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2091-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2090-2025	Class III	Completed	Voluntary: Firm initiated	2025-07-16	2025-07-07
Z-2091-2025	Class III	Completed	Voluntary: Firm initiated	2025-07-16	2025-07-07
Z-2092-2025	Class III	Completed	Voluntary: Firm initiated	2025-07-16	2025-07-07
Z-2093-2025	Class III	Completed	Voluntary: Firm initiated	2025-07-16	2025-07-07
Z-2094-2025	Class III	Completed	Voluntary: Firm initiated	2025-07-16	2025-07-07

Product code EBI

K220771Class IIStratasys TrueDentStratasys, Ltd. / cleared 2022-07-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)