K2M, Inc: Medical Device Recall in 2019 - (Recall #: Z-1492-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 18, 2019

Date Posted: June 5, 2019

Recall Number: Z-1492-2019

Event ID: 82716

Reason for Recall:

The products are mislabeled.

Status: Terminated

Product Quantity: 462 total

Code Information:

All lots in distribution

Distribution Pattern:

The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated