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.
Recall
- Recall Number
- Z-1492-2019
- Event Number
- 82716
- FEI Number
- 3008599177
- Product Code
- KNW
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 18, 2019
- Terminated
- June 19, 2020
- Address
- K2M Inc 600 Hope Pkwy SE, Leesburg, VA, 20175-4428
Description
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.
The products are mislabeled.
Urgent Medical Device Recall notification letters dated 4/18/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions contact the Regulatory Compliance Team: [email protected] or 201.749.8090.
The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.
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