Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure
Biomet 3i is recalling 250 Contra-Angle Torque Driver Kits because the included surgical 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 or harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Biomet 3i, LLC is recalling 250 units of the Contra-Angle Torque Driver Kit for Certain Internal Connection. The product consists of a molded plastic tray used to hold various dental instruments for autoclave processing. The recall is being conducted because recent revised sterilization validation testing revealed that the included surgical trays did not meet the required Sterility Assurance Level.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries. The specific product code associated with this recall is NCATD0C (PSDT1). No specific dates of distribution or installation are provided in the source text.
Consumers and healthcare providers who possess these kits should stop using them and contact Biomet 3i, LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
- Manufacturer
- Biomet 3i, LLC
- Hazard
- Affected units
- 250
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)
- NCATD0C (PSDT1)
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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