Device product
ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.
Z-1729-2021
Product summary
- Firm
- Zavation
- Event
- Event 87661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-1729-2021
Official wording
Reason: Products distributed as sterile may not have been adequately sterilized
Code information: Lot: 20071774, 19123262
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Sterility assurance
may not have been adequately sterilized