Device product
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.
Z-1709-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72 units
- Official record key
device-enforcement:Z-1709-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: Lot: 2003661, 19113051, 20071709, 20071843
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized