Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fenestrated Taps 4.5mm Recalled by K2M, Inc Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact K2M, Inc directly.
Affected Products
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.
Quantity: 462 total
Why Was This Recalled?
The products are mislabeled.
Where Was This Sold?
This product was distributed to 6 states: FL, KY, MI, PA, SC, WV
About K2M, Inc
K2M, Inc has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report