Device product
ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
Z-1759-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 516 units
- Official record key
device-enforcement:Z-1759-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: Lot Numbers: 13378ZV, 11141ZV, 10815ZV, 13971ZV, 13921ZV, 13577ZV, 13133ZV, 13033ZV, 11793ZV, 11695ZV, 12132ZV, 14105ZV, 12280ZV, 14389ZV, 13884ZV, 11956ZV, 11470ZV, 11342ZV, 10902ZV, 10516ZV, 14358ZV, 12266ZV, 10866ZV, 10651ZV, 14207ZV, 14021ZV, 11231ZV, 11465ZV, 12025ZV, 11537ZV, 11415ZV, 10998ZV, 11072ZV, 13883ZV
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized