Nakanishi Inc.: Medical Device Recalls in 2016

According to to data from the FDA, there were 3 medical device recalls made by Nakanishi Inc. in 2016. See the details of the recalls below.

You can see similar recalls for other firms.

• 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.
• 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 such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing).
• 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 lift, and implant preparation.