Recall Z-2674-2016 ยท EFB Handpiece, Air-Powered, Dental
Nakanishi Inc.
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.
| Date | Jul 8, 2016 |
| Status | Terminated |
| Reason | 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 Nakanish |
| Root cause | Error in labeling |
| Action | Naknishi sent out an URGENT : MEDICAL DEVICE CORRECTION letter on July 18, 2016 describing the potential safety issue regarding their Diamond Coated Products. The firm is requesting customers take the following actions: 1. Examine their inventory immediately to determine if they have any product, both used and unused, bearing any of the Nakanishi Product Codes listed in List of Products enclosed with this letter. 2. Immediately dispose of any USED product according to applicable regulations. 3. Segregate any UNUSED product for return to Nakanishi. 4. In order for the firm to compl |
| Quantity | 4284 units |
| Distribution | Nationwide Distribution to Illinois, Florida and Georgia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962543 | ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU Nsk Nakanishi, Inc., Sep 11, 1996 |