Device product
ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.
Z-1766-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-1766-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: Lot Numbers: 13650ZV, 13518ZV, 11677ZV, 11678ZV, 10514ZV
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized