Device product
CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051
Z-1635-2021
Product summary
- Event
- Event 87696
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 units
- Official record key
device-enforcement:Z-1635-2021
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.