Omnia Medical recalls TiBrid Stand Alone Intervertebral Body Fusion Devices and angled screwdrivers due to potential field failure. Affected models include 17-5A-DV45, 17-5A-DV60 with specific UDI numbers.
Failure of fusion system instruments in the field.
Omnia Medical is recalling TiBrid spine fusion devices and angled screwdrivers because they may fail in the field. This could lead to improper spinal fusion procedures if used without the intended safety features.
The devices may fail during use, which could result in improper spinal fusion. This failure might cause complications such as misaligned bones or inadequate healing.
Patients who have received the recalled TiBrid devices or screwdrivers for spinal fusion surgery are likely affected. Surgeons and medical staff using these devices during procedures are at higher risk.
Check for model numbers 17-5A-DV45 or 17-5A-DV60 on the device packaging. The Unique Device Identification (UDI) numbers 00843511122041, 00843511122058, or 00843511122065 are also associated with these products.
Look for model numbers 17-5A-DV45 or 17-5A-DV60 on the device packaging.
Check if the device has UDI numbers 00843511122041, 00843511122058, or 00843511122065.
The affected devices are TiBrid Stand Alone Intervertebral Body Fusion Devices and TiBrid SA Angled Screwdrivers with model numbers 17-5A-DV45 or 17-5A-DV60.
Check for model numbers 17-5A-DV45 or 17-5A-DV60 on the device packaging, or UDI numbers 00843511122041, 00843511122058, or 00843511122065.
The recall record does not specify a remedy, so contact Omnia Medical directly for guidance.
We’ve drafted a message you can send Omnia Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2557-2025 — Omnia Medical Omnia Medical Hello, I own a Omnia Medical that is covered by recall Z-2557-2025 from Omnia Medical. 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.
