Device product
VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.
Z-1769-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 140 units
- Official record key
device-enforcement:Z-1769-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: Lot Numbers: 10085ZV, 10086ZV, 11205ZV, 11217ZV, 11554ZV, 11558ZV, 11559ZV
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized