Recall Z-1492-2019— K2M, Inc

Name: FDA recall Z-1492-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-18

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 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.. 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 record

K152872 — K2M Fenestrated Tap SystemK2m·cleared 2016-01-05

K-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 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.

Reason for recall

The products are mislabeled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.