Recall Z-0223-2019 ยท KMW Handpiece, Rotary Bone Cutting
Nakanishi Inc.
Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
| Date | Oct 24, 2018 (initiated Jun 1, 2018) |
| Status | Terminated |
| Reason | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals. |
| Root cause | Device Design |
| Action | On 7/3/2018, the recalling firm, NSK, initiated sending "URGENT: MEDICAL DEVICE RECALL- CORRECTION" notification letters, via email and mail, by YUSEN Logistics. The recalling firm reports that the initial importers were given the responsibility for sub-recalls to their customers and to extend to the wholesaler, the retailer, and the end user (medical user). Customers were informed to Locate the operation manuals associated with your SGS/SGA Surgical Handpiece; Dispose of the any of the following previous operation manuals associated with those handpieces you may have and replace them with |
| Quantity | 2419 |
| Distribution | U.S. Distribution to states of: CA, FL, GA, IL, WA.; and internationally to: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece Nakanishi, Inc., Nov 21, 2017 |