The Recall Desk
HighFDA (Devices)·Z-2673-2016·Announced 2016-09-07

Nakanishi Diamond Coated Tips Recalled for Missing Single-Use Labeling

Nakanishi Inc. is recalling 2,574 diamond coated tips and burs because the labeling failed to indicate they are single-use only, posing a cross-contamination risk.

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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.

Plain-English summary

Nakanishi Inc. is recalling 2,574 units of Diamond Coated Tips and Burs, which are accessories for the VARIOSURG air-powered bone drill. The recall was initiated because the product labeling failed to include the symbol or text indicating that the tips are single-use only. The tips are made of stainless steel with a diamond powder coating and are sold non-sterile, requiring sterilization prior to first use.

The error occurred because in other markets, such as Japan, these tips are approved for multiple uses. The issue was discovered during a quality system improvement plan initiated by Nakanishi in October 2014. Because the correct sterilization instructions for single-use devices are not available, there is a risk that the devices may not be sterile prior to use if reprocessed and reused, leading to potential cross-contamination.

The products were distributed nationwide to Illinois, Florida, and Georgia. The source text does not specify specific actions for consumers or healthcare providers, but the hazard is identified as a risk of cross-contamination due to the absence of single-use instructions.

The recalled product

Product
Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus
Manufacturer
Nakanishi Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
2,574

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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