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Terminated

SX-One MicroKnife

FDA Recall Z-1387-2022 · Posted None

Recalling FirmSONEX HEALTH LLC
Recall StatusTerminated
Product CodeLXH
Date Initiated2022-06-29
Date Terminated2023-04-14
Product Quantity3,752 devices

Reason for Recall

Potential of dull blade

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K192873SX-One MicroKnifeSonex Health, Inc. · 2019-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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