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 t...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2674-2016.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2674-2016.
Recall terminated by FDA.
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- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2674-2016.
Nakanishi Inc.
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Nakanishi Inc. Recall FAQ
Nakanishi Inc. is the subject of a medical devices safety report: 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 t.... The notice was published on July 8, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 4,284 units are potentially affected.