Device product
SX-One MicroKnife
Z-1387-2022
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
Potential of dull blade