FDA recall Z-1387-2022
SONEX HEALTH LLC · Class II · device
Product
SX-One MicroKnife
Reason for recall
Potential of dull blade
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.
Key facts
- Status
- Terminated
- Initiation date
- 2022-06-29
- Report date
- 2022-07-27
- Termination date
- 2023-04-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Eagan, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1387-2022