Biomet 3i Recalls Tapered Navigator Surgical Kits Due to Sterility Failure
Biomet 3i is recalling 170 Tapered Navigator Certain Surgical Kits because the trays failed to meet required sterility assurance levels during validation testing.
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: The recall is classified as FDA Class II, and the failure to meet sterility assurance levels presents a risk of infection (risk-of-harm) without reported injuries, fitting the 'High' severity criteria.
Plain-English summary
Biomet 3i, LLC is recalling 170 units of the Tapered Navigator Certain Surgical Kit. These products are molded plastic trays used to hold various dental instruments for autoclave processing. The recall is being conducted because the surgical trays did not meet the required Sterility Assurance Level during recent revised sterilization validation testing.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. The specific product code associated with the recall is SGTIKIT (SGTTRAY).
Consumers and healthcare providers should stop using these surgical trays immediately. They should contact Biomet 3i, LLC for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
- Manufacturer
- Biomet 3i, LLC
- Affected units
- 170
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)
- SGTIKIT (SGTTRAY)
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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