Stradis Healthcare Dental Implant Trays Recalled Due to Incomplete Sealing
Stradis Healthcare is recalling dental implant trays with incomplete outer bag seals that may compromise sterility. Affected units were distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device with a manufacturing defect that creates a risk of sterility breach—a serious concern for surgical implants. Although no illnesses or injuries have been reported and the hazard is potential rather than confirmed, a sterility breach on a device intended for implantation represents a high-risk scenario.
Plain-English summary
Stradis Healthcare is recalling STRADIS HEALTHCARE dental implant trays, Item No. 41015NSI, due to a manufacturing defect that may result in incomplete sealing of the outer bag.
The incomplete seal may allow a breach in the sterility of the kit. While no illnesses or injuries have been reported, the affected trays pose a potential risk if implanted, as the sterility cannot be guaranteed.
The recall affects 30 units with lot number 22230491043. These trays were distributed nationwide in the United States and Canada. Healthcare providers and patients who have received these trays should contact Stradis Medical, LLC dba Stradis Healthcare for further instructions.
The recalled product
- Product
- STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Dental Implant
- Affected units
- 30
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 (3)
- UDI/DI (case) M75241015NSI1
- UDI/DI (kit)M75241015NSI0
- Serial/Lot Numbers: 22230491043
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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