TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental a
FDA device recall Z-2090-2025 · posted 2025-07-07 · Completed
Recall details
- Recalling firm
- STRATASYS LTD
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Completed
- Product code
- EBI
- Quantity affected
- 78
- Distribution
- US Nationwide distribution including in the states of Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, New York,
- Date initiated
- 2024-01-19
- Date posted
- 2025-07-07
- Location
- Rehovot, Israel
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Stratasys TrueDent (K220771) | Stratasys, Ltd. | 2022-07-07 |