Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Velofix SA cervical cage Recalled by U&I CORP. Due to The vertical dimensions of screw-hole position in some...
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 U&I CORP. directly.
Affected Products
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.
Quantity: 42
Why Was This Recalled?
The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About U&I CORP.
U&I CORP. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report