The Recall Desk
HighFDA (Devices)·Z-0494-2023·Announced 2022-12-21

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
Category
Medical Device — Surgical instruments
Hazard
  • seal-defect
  • sterility-breach

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.

Related recalls

Same category