Device product
Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
Z-1492-2019
Product summary
- Firm
- K2M, Inc
- Event
- Event 82716
- Status
- Terminated
- Classification
- Class II
- Quantity
- 462 total
- Official record key
device-enforcement:Z-1492-2019
Official wording
Reason: The products are mislabeled.
Code information: All lots in distribution
Distribution pattern: The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.
Derived failure modes
-
Labeling or packaging
mislabeled