Nakanishi Inc.: Medical Device Recall in 2016 - (Recall #: Z-2674-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 8, 2016

Date Posted: September 7, 2016

Recall Number: Z-2674-2016

Event ID: 74666

Reason for Recall:

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.

Status: Terminated

Product Quantity: 4284 units

Code Information:

Waiting for clarification from the firm.

Distribution Pattern:

Nationwide Distribution to Illinois, Florida and Georgia.

Voluntary or Mandated:

Voluntary: Firm initiated