Recall Z-1387-2022 ยท LXH Orthopedic Manual Surgical Instrument
SONEX HEALTH LLC
SX-One MicroKnife
| Date | Jun 29, 2022 |
| Status | Terminated |
| Reason | Potential of dull blade |
| Root cause | Process control |
| Action | On 06/29/2022, Sonex Health notified consignees of the recall via emailed letter titled, "URGENT MEDICAL DEVICE RECALL." The letter instructed consignees to check inventory for affected devices, cease use of the devices and remove them from point of use, notify all applicable personnel or recipients if the product was further distributed or transferred, complete and return the provided response form, and arrange for the return of affected devices. |
| Quantity | 3,752 devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, KS, MD, MI, MN, MT, NE, NJ, NV, NY, OH, OK, OR, PA, TX, UT, VA, WI, WV, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192873 | SX-One MicroKnife Sonex Health, Inc., Dec 20, 2019 |