Device product
InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures.
Z-1752-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 178 units
- Official record key
device-enforcement:Z-1752-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: a) INTVM-15-FLDSK, Lot Numbers:10342ZV, 12525ZV, 12267ZV, 12011ZV, 10545ZV, 10048ZV, 11861ZV, 11343ZV, 11037ZV, 10780ZV, 11102ZV b) INTVM-20-FLDSK, Lot Numbers: 10312ZV, 11698ZV, 10276ZV, 10205ZV, 10031ZV
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized