Z-1387-2022Class II

SX-One MicroKnife

Name: Z-1387-2022 SX-One MicroKnife
Creator: Sonex Health Llc
Published: 2022-06-29
License: https://open.fda.gov/license/

SONEX HEALTH, Inc / initiated 2022-06-29 / Terminated / root cause: manufacturing process

FDA source

SONEX HEALTH LLC began a recall of SX-One MicroKnife on 2022-06-29. FDA classified it as Class II and gives the reason as "Potential of dull blade". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1387-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-29
Posted: 2022-07-15
Terminated: 2023-04-14
Recalling firm: SONEX HEALTH, Inc
Product: SX-One MicroKnife
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Potential of dull blade
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1387-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1387-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-15

Product code LXH

K192873Class ISX-One MicroKnifeSonex Health, Inc. / cleared 2019-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)