Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) 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.
The products are mislabeled.
The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1491-2019