Recall Z-1491-2019— K2M, Inc
Class II · Terminated
Class II FDA medical device recall by K2M, Inc, initiated 2019-04-18, terminated 2020-06-19. It names one FDA 510(k) clearance: K152872. Product: 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.. Reason: The products are mislabeled..
- Recalling firm
- K2M, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-18
- Terminated
- 2020-06-19
- Firm location
- Leesburg, VA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The products are mislabeled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.