U&I CORP. recalls Velofix SA cervical cages with specific reference numbers due to potential screw pullout or instability. Affected models may not engage bone properly as intended by physicians.
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.
U&I CORP. is recalling specific Velofix SA cervical cage models because some have screw holes that might be misaligned. This could lead to screws pulling out, causing instability or less effective bone fusion than planned by doctors.
The screw holes in some cages might be positioned outside engineering specifications. This could cause screws to pull out, become loose, or not engage bone properly as intended by doctors during spinal fusion.
Skeletally mature patients undergoing cervical spine fusion surgery with the recalled Velofix SA cages. Surgeons using these specific models during procedures are most at risk.
Check for reference numbers TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, or TSA161410 on the cage. The affected models were produced in lots A18K220, A18L065, A18L013, A18L014, A18L015, A18L018, A18L019, or A18L020, A18L021.
Look for reference numbers TSA161207 through TSA161410 on the cage to confirm if it's affected.
The screw holes in some cages might be misaligned, which could cause screws to pull out, become loose, or not engage bone properly as intended by doctors.
Velofix SA cervical cages with reference numbers TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, or TSA161410.
Check the product reference numbers to see if it's affected. If it is, contact U&I CORP. for further instructions.
We’ve drafted a message you can send U&I CORP. to request your refund or repair — edit it as you like.
Subject: Recall Z-1823-2020 — U&I CORP. U&I CORP. Hello, I own a U&I CORP. that is covered by recall Z-1823-2020 from U&I CORP.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
