Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cortera Spinal Fixation System Screw Recalled by XTANT Medical Holdings, Inc Due to Spinal fixation system implant screws marked "DNI" are...
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 XTANT Medical Holdings, Inc directly.
Affected Products
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Quantity: 330
Why Was This Recalled?
Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About XTANT Medical Holdings, Inc
XTANT Medical Holdings, Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report