Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Recalled by Genesys Orthopedic Systems, LLC Due to Manufacturing residue may be present on the cervical...
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 Genesys Orthopedic Systems, LLC directly.
Affected Products
3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
Quantity: 9 cervical screws
Why Was This Recalled?
Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Genesys Orthopedic Systems, LLC
Genesys Orthopedic Systems, LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report