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Recall Observatory FDA recall evidence

Device product

SX-One MicroKnife

Z-1387-2022

June 29, 2022

Class II

Product summary

Firm
SONEX HEALTH LLC
Event
Event 90520
Status
Terminated
Classification
Class II
Quantity
3,752 devices
Official record key
device-enforcement:Z-1387-2022

Official wording

Reason: Potential of dull blade

Code information: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential of dull blade