Omnia Medical recalls TiBrid Stand Alone Intervertebral Body Fusion Devices with SA Angled Punch Awl models 17-5A-AWL3, 17-5A-AWL4, and 17-5A-AWL5 due to potential field instrument failure.
Failure of fusion system instruments in the field.
Omnia Medical is recalling specific TiBrid fusion devices that may fail in the field. This could lead to complications during spinal surgery if used improperly.
The fusion system instruments can fail during use, potentially causing complications in spinal surgery. This failure could occur in the field without warning.
Surgical teams using the recalled TiBrid devices for spinal fusion procedures are most at risk. Patients undergoing surgery with these devices may face complications.
Check for model numbers 17-5A-AWL3, 17-5A-AWL4, or 17-5A-AWL5 on the device. The UDI codes 00843511113056, 00843511122287, and 00843511122294 are also associated with these models.
Look for model numbers 17-5A-AWL3, 17-5A-AWL4, or 17-5A-AWL5 on the device.
TiBrid Stand Alone Intervertebral Body Fusion Devices with SA Angled Punch Awl models 17-5A-AWL3, 17-5A-AWL4, and 17-5A-AWL5.
Check for model numbers 17-5A-AWL3, 17-5A-AWL4, or 17-5A-AWL5 on the device. The UDI codes 00843511113056, 00843511122287, and 00843511122294 are also associated with these models.
The recall record does not specify a remedy or action for affected devices.
We’ve drafted a message you can send Omnia Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2556-2025 — Omnia Medical Omnia Medical Hello, I own a Omnia Medical that is covered by recall Z-2556-2025 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.
