K2M, Inc: The products are mislabeled.

Agency Publication Date: May 25, 2019

Affected Products

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

All lots in distribution

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 usi

All lots in distribution

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82716

Status: Resolved

Manufacturer: K2M, Inc

Manufactured In: United States

Units Affected: 2 products (462 total)

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Sources: FDA iRES · Raw API Response

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Affected Products

All lots in distribution