The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1170-2014·Announced 2014-03-19

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.

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. 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
Category
Medical Device — Dental Instrument
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

Distributed nationwide across the United States.

The notice also names 39 states specifically:

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.

See all 5 products in this recall →

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