Novapproach recalls OneLIF Interbody Cages with specific model numbers due to potential failure to attach to cages, which may cause procedural delays or require alternative implants during spinal surgery.
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.
Novapproach is recalling specific OneLIF Interbody Cage models used in spinal surgery because the straight inserter may not attach properly to the cages. This could lead to surgery delays or needing a different implant.
The straight inserter in the recalled cages may fail to securely attach to the cages during spinal fusion procedures. This could cause the surgery to be delayed or require switching to an alternative implant.
Patients who have received the recalled OneLIF Interbody Cages during spinal surgery are affected. Surgeons and medical staff using these specific models are most at risk.
Check the model numbers listed in the recall notice: 010-107-1007, 010-107-1007-2, 010-107-1209, and other specific codes. The recall includes implant kits with these cages.
Inform your surgeon about the recalled model numbers to determine if you have the affected cages.
No, the recall does not require stopping use. The issue is about potential procedural delays during surgery, not a safety hazard that requires immediate action.
Contact your surgeon to discuss whether the cages need to be replaced or if alternative implants are required.
Check the model numbers listed in the recall notice, such as 010-107-1007 or 010-107-1007-2, which are included in the affected implant kits.
We’ve drafted a message you can send Novapproach to request your refund or repair — edit it as you like.
Subject: Recall Z-2213-2026 — Novapproach Novapproach Hello, I own a Novapproach that is covered by recall Z-2213-2026 from Novapproach. 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.
