Device product
InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.
Z-1755-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 119 units
- Official record key
device-enforcement:Z-1755-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: a) INTVMN-10-DSK, Lot Numbers: 12200ZV b) INTVMN-15-DSK, Lot Numbers: 10816ZV, 13708ZV, 13845ZV, 13522ZV, 12133ZV c) INTVMN-15-DSKC, Lot Numbers: 11843ZV, 11412ZV, 11160ZV, 11017ZV d) INTVMN-20-DSK, Lot Numbers: 14266ZV, 14238ZV, 12524ZV, 11756ZV, 11083ZV
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized