K2M product recalled over labeling errors

Recall date

April 18, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

K2M, Inc recalls Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standa…

Recall number

Z-1492-2019

FDA classification

Class II

Brand / firm

K2M, Inc

Sold / distributed

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

Why it was recalled

The products are mislabeled.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.