Surgical Implant Trays Recalled for Incomplete Package Seal
Stradis Healthcare is recalling 162 surgical implant trays distributed nationwide due to incomplete outer bag seals that may compromise sterility.
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 involving a surgical device with potential sterility breach as a risk-of-harm product. No illnesses or injuries have been reported, keeping the hazard theoretical rather than confirmed.
Plain-English summary
Stradis Medical, LLC (dba Stradis Healthcare) is recalling 162 units of Item No. 41111UTI surgical implant packs for use in oral surgery. These products were distributed nationwide and in Canada.
Manufacturing processes resulted in certain conditions that may cause the outer packaging bags to be incompletely sealed. An incompletely sealed bag may result in a breach in the sterility of the surgical kit, which protects the instruments from contamination.
Affected units can be identified by lot number 22229491074 and UDI designation M7524111UTI0. The recall was classified as FDA Class II. No illnesses or injuries related to this defect have been reported.
The recalled product
- Product
- Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 162
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) M7524111UTI0
- UDI/DI (kit)M7524111UTI0
- Serial/Lot Numbers: 22229491074
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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