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.
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 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.
- 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
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.
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