SX-One MicroKnife recallZ-1387-2022 · Sonex Health LLC · initiated Jun 29, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sonex Health LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential of dull blade
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1387-2022
- Status
- Terminated
- Initiated by the company
- Jun 29, 2022
- Recalling firm
- Sonex Health LLC
- Quantity
- 3,752 devices
- Product code
- LXH
- FDA submissions
- K192873
- 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.
Product description
SX-One MicroKnife
Code information (models, lots, serial numbers)
Part Number 600112-001; UDI-DI: 00860002094700; Lot Codes: 20013120, 20022821, 20022822, 20022823, 20022824, 20022825, 20070603, 20070604, 20080435, 20080436, 20083114, 20083115, 40051, 40052, 40472, 40473, 40892, 40893, 41460, 41584, 41585.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SX-One MicroKnife 600112-001Sonex Health, Inc. · Orthopedic Manual Surgical Instrument1 recall6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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