Z-1387-2022 Class II Terminated
FDA device recall Z-1387-2022 was initiated by SONEX HEALTH LLC on June 29, 2022 and is designated Class II. Reason for recall: Potential of dull blade The recall status is terminated (terminated April 14, 2023). Affected quantity: 3,752 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- June 29, 2022
- Termination Date
- April 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,752 devices
Product Description
SX-One MicroKnife
Reason for Recall
Potential of dull blade
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.
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.