FDA recall Z-1703-2021
Zavation · Class II · device
Product
ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.
Reason for recall
Products distributed as sterile may not have been adequately sterilized
Distribution
US nationwide distribution.
Key facts
- Status
- Terminated
- Initiation date
- 2021-03-25
- Report date
- 2021-06-09
- Termination date
- 2023-03-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Flowood, MS, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1703-2021