The Recall Desk
HighFDA (Devices)·Z-2674-2016·Announced 2016-09-07

Nakanishi Diamond Coated Dental Tips Recalled for Missing Single-Use Labeling

Nakanishi Inc. is recalling 4,284 diamond coated dental tips because the packaging failed to indicate they are single-use only, posing a risk of cross-contamination.

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 risk of cross-contamination due to missing single-use labeling, which fits the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Nakanishi Inc. is recalling 4,284 units of Diamond Coated Tips and Burs, which are accessories for the S-MAX pico air-powered dental handpiece. These stainless steel tips, coated with fine diamond powder, are intended for general dental actions such as removing carious material and polishing teeth. The recall is due to a labeling error where the packaging failed to include the symbol or text indicating that the tips are single-use only.

The error occurred because in other markets, such as Japan, these tips are approved for multiple uses. The tips are sold non-sterile and require sterilization prior to first use. Because the correct instructions for sterilization are not available for these specific single-use units, there is a possibility that the devices might not be sterile before use. The absence of the single-use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.

The issue was discovered during a quality system improvement plan initiated by Nakanishi in October 2014. The products were distributed nationwide to Illinois, Florida, and Georgia. Consumers and dental professionals should stop using these tips and contact Nakanishi Inc. for further instructions.

The recalled product

Product
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reduc
Manufacturer
Nakanishi Inc.
Category
Medical Device — Dental Accessories
Hazard
Affected units
4,284

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)

  • Waiting for clarification from the firm.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Nakanishi Inc. 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 3 products in this recall →

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