Device product
ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
Z-1758-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-1758-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: Lot Numbers: 12872ZV, 12406ZV, 11934ZV
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized