Device product
ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal procedures.
Z-1767-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 units
- Official record key
device-enforcement:Z-1767-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: Lot Numbers: 11958ZV, 14393ZV, 11726ZV, 11107ZV, 10955ZV
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized