Device product
ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures.
Z-1765-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 302 units
- Official record key
device-enforcement:Z-1765-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: Lot Numbers: 13978ZV, 13966ZV, 13873ZV, 13643ZV, 13185ZV, 12594ZV, 11766ZV, 11548ZV, 11391ZV, 11139ZV, 10781ZV, 14390ZV, 13976ZV, 13711ZV, 13413ZV, 12930ZV, 12331ZV, 12300ZV, 12199ZV, 14349ZV, 11271ZV, 11847ZV, 11274ZV
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized