Dental resin cartridges recalled for expiration date formatting error
Stratasys recalled approximately 109 units of TrueDent White dental resin cartridges due to an expiration date formatting error. The error prevents system detection of expired material, creating risk that expired resin could be unknowingly used in dental appliances.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product recall involving expired dental resin that could be unknowingly used in patient dental appliances due to a system formatting error. No injuries have been reported, but expired resin in medical device manufacturing presents potential risk of harm.
Plain-English summary
Stratasys LTD is recalling TrueDent White, TDM110 (Model No. OBJ-09168), a light-curable methacrylate-based resin used to fabricate dental appliances. Approximately 109 units of the affected product (Lot 22377, expired October 12, 2023; UDI-DI: 7290018915202) have been distributed.
The recall is prompted by an expiration date formatting error in the system that transposes the day and month of the expiration date. This error prevents proper system recognition of expired material, creating a risk that users may unknowingly use expired resin in dental appliances.
The affected product has been distributed nationwide across 19 U.S. states: Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, Nebraska, New York, North Carolina, North Dakota, Oklahoma, Oregon, Utah, and Wisconsin. Anyone with affected inventory should contact the manufacturer regarding next steps.
The recalled product
- Product
- TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
- Manufacturer
- STRATASYS LTD
- Category
- Medical Device — Dental resins
- Hazard
- expiration-date-error
- expired-product-risk
- system-detection-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 7290018915202 Lot 22377 (exp. 12-Oct-2023)
Distribution
Distributed nationwide across the United States.
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