Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cortera Spinal Fixation System Recalled by XTANT Medical Holdings, Inc Due to Spinal fixation screws labeled as 8.5 mm diameter,...
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, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Quantity: 6
Why Was This Recalled?
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
Where Was This Sold?
This product was distributed to 1 state: MI
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