Recall Z-2093-2025— STRATASYS LTD
Class III · Completed
Class III FDA medical device recall by STRATASYS LTD, initiated 2024-01-19. It names one FDA 510(k) clearance: K220771. Product: TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances. 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..
- Recalling firm
- STRATASYS LTD
- Classification
- Class III
- Status
- Completed
- Initiated
- 2024-01-19
- Firm location
- Rehovot, N/A, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
TrueDent Yellow, TDM140, Model No. OBJ-09169 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.