Device product
EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
Z-1636-2021
Product summary
- Event
- Event 87696
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-1636-2021
Official wording
Reason: Products labeled as sterile were distributed, but may not have been sterilized.
Code information: BATCH:2003721
Distribution pattern: US Nationwide distribution in the states MS and KY.
Derived failure modes
-
Unknown
Products labeled as sterile were distributed, but may not have been sterilized.