STRATASYS LTD — TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 19, 2024
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.
What's affected?
- Product
- TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Brand
- STRATASYS LTD
- Lot code
- 22994
Additional details
UDI-DI 7290018915004 Lots 22994 (exp. 02-Apr-2024) and 23425 (exp. 07-Nov-2024)
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 78.
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