Reported Sep 7, 2016 · Terminated
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the…
Nakanishi Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nakanishi Inc. · 700 · Kanuma, N/A · N/A
Is this the product you have?
- 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, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
- Lot codes and dates
- Waiting for clarification from the firm.
- Amount recalled
- 4284 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only. This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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