Device product
OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.
Z-1768-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 846 units
- Official record key
device-enforcement:Z-1768-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: Lot Numbers: 13844ZV, 12320ZV, 14359ZV, 14171ZV, 13887ZV, 12670ZV, 11759ZV, 11850ZV, 13750ZV, 14273ZV, 14017ZV, 13665ZV, 12766ZV, 12037ZV, 14100ZV, 11693ZV, 14472ZV, 14388ZV, 13651ZV, 13876ZV
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized