Recall Z-2091-2025 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
STRATASYS LTD
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
| Date | Jul 7, 2025 (initiated Jan 19, 2024) |
| Status | Completed |
| 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220771 | Stratasys TrueDent Stratasys, Ltd., Jul 7, 2022 |