# FDA recall Z-1491-2019

> **K2M, Inc** · Class II · device recall initiated 2019-04-18.

## 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 for recall

The products are mislabeled.

## Distribution

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

## Key facts

- **Recall number:** Z-1491-2019
- **Recalling firm:** K2M, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-18
- **Report date:** 2019-06-05
- **Termination date:** 2020-06-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Leesburg, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1491-2019

## Citation

> AI Analytics. FDA recall Z-1491-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1491-2019. Source: US FDA. Licensed CC0.

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