BASIC IMPLANT PACK Recalled for Incomplete Outer Bag Sealing
Stradis Medical is recalling the BASIC IMPLANT PACK (Item 40310SBI) due to incomplete outer bag sealing that may compromise sterility. 80 units were distributed nationwide and in Canada.
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 an FDA Class II recall for a potential sterility breach in a surgical implant kit. While a compromised sterility barrier poses genuine risk of harm in surgical applications, no illnesses or injuries have been reported. Per the rubric, when hazard is theoretical and no injuries are reported, the score is at most High.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling the BASIC IMPLANT PACK, Item No. 40310SBI, an oral surgery tray. The recall affects 80 units that were distributed nationwide in the US and Canada.
During manufacturing, the outer bag of the kit may not be completely sealed. An incompletely sealed outer bag may result in a breach of the kit's sterility, which can allow contamination and poses a risk to patients receiving surgical treatment with the implant.
No illnesses or injuries have been reported to date associated with this recall.
Healthcare facilities and practitioners with affected units bearing Serial/Lot Number 22241489853 should contact Stradis Medical, LLC dba Stradis Healthcare for return or replacement instructions.
The recalled product
- Product
- BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- sterility-breach
- contamination-risk
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) M75240310SBI1
- UDI/DI (kit)M75240310SBI0
- Serial/Lot Numbers: 22241489853
Distribution
Distributed nationwide across the United States.
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