The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1171-2014·Announced 2014-03-19

Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

Biomet 3i is recalling 181 dental torque driver kits because they 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 Level, which poses a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomet 3i, LLC is recalling 181 units of the Contra-Angle Torque Driver Kit. These kits consist of molded plastic trays 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 products were distributed worldwide, including nationwide in the United States and in numerous international countries such as Canada, Germany, Japan, and the United Kingdom. The specific product code associated with the recall is NPSDK0 aka PSKDO (PSKDT1).

Consumers and dental professionals should stop using these trays immediately and contact Biomet 3i, LLC for instructions on how to return or dispose of the affected units. The recall is driven by a failure in the sterilization validation process, which raises concerns about the ability of the trays to maintain sterility during autoclave processing.

The recalled product

Product
Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Instruments
Hazard
Affected units
181

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)

  • NPSDK0 aka PSKDO (PSKDT1)(

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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