Device product
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.
Z-1706-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1706-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: lot: 20071860, 2004988, 19113040, 20071775
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized