Nakanishi Diamond Coated Tips Recalled for Missing Single-Use Labeling
Nakanishi Inc. is recalling 30,719 diamond coated tips and burs because 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 cross-contamination and potential lack of sterility in a medical device, which fits the rubric for 'risk-of-harm products where injury has not yet been reported.' No illnesses or injuries are reported in the source text.
Plain-English summary
Nakanishi Inc. is recalling 30,719 units of Diamond Coated Tips and Burs, which are accessories for VARIOS ultrasonic scalers. 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 fine 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 use. The issue was identified during a quality system improvement plan initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available on the packaging, there is a possibility that the devices may not be sterile prior to use. The absence of the single-use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.
The affected products were distributed nationwide to Illinois, Florida, and Georgia. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items, nor does it provide specific lot numbers or expiration dates.
The recalled product
- Product
- Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various…
- Manufacturer
- Nakanishi Inc.
- Affected units
- 30,719
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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