Biomet 3i Recalls Navigator Surgical Kits Due to Sterility Assurance Failure
Biomet 3i, LLC is recalling 21 units of the Navigator Surgical Kit because the trays failed to meet required sterility assurance levels during validation testing.
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: The recall is classified as FDA Class II. The hazard involves a failure to meet sterility assurance levels, which poses a risk of infection (risk-of-harm), but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Biomet 3i, LLC is recalling 21 units of the Navigator Surgical Kit. This product is a molded plastic tray used to hold various dental instruments for autoclave processing. The recall was initiated after recent revised sterilization validation testing revealed that the included surgical trays did not meet the required Sterility Assurance Level.
The affected product is identified by the code SGKIT (SGTRAY). The recall covers a worldwide distribution, including the United States (nationwide, including Hawaii and Puerto Rico) and numerous international countries such as Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.
Consumers and healthcare providers should stop using the affected Navigator Surgical Kits immediately. The source text does not specify further instructions for disposal or replacement, but users should contact Biomet 3i, LLC for guidance on how to proceed.
The recalled product
- Product
- Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
- Manufacturer
- Biomet 3i, LLC
- Affected units
- 21
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)
- SGKIT (SGTRAY)
Distribution
Part of a larger recall action
This product is one of 5 recalled by Biomet 3i, LLC 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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