The Recall Desk

FDA (Devices) recall action 74666

Nakanishi Inc. recalled 3 products on 2016-09-07

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2016-09-07
Critical
0
Units
37,577

Why these products were 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 Nakani…

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2016-09-07

    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.

    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
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2016-09-07

    Nakanishi Diamond Coated Dental Tips Recalled for Missing Single-Use Labeling

    Nakanishi Inc. is recalling 4,284 diamond coated dental tips because the packaging failed to indicate they are single-use only, posing a risk of cross-contamination.

    Product
    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, reduc
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2016-09-07

    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.

    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 actions
    Category
    Distribution
    3 states