Omnia Medical issued a recall for 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device and TiBrid SA Angled Screwdrivers after field failures were reported. The recall covers nationwide distribution in AZ, CA, NJ, NV, OK and WA. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
Failure of fusion system instruments in the field.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Omnia Medical or your healthcare provider for instructions. Notification method: Telephone
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TiBrid devices are used in spinal fusion procedures. They are designed to stabilize the spine during fusion.
Field-instrument failure can compromise the fusion procedure and pose risk to patients during surgery.
This recall is not clearly described as part of a broader industry pattern in the provided data.
This recall could cause surgical delays or changes in planned fusion surgeries, requiring clinicians to switch instruments mid-procedure.
Refer to the FDA enforcement report page for Z-2557-2025 recall details.
Remedy processing timelines are determined by Omnia Medical per recall instructions.
Keep recall notices, model numbers, distribution list, and communication records
Brand: Omnia Medical. Product: TiBrid Stand Alone Intervertebral Body Fusion Device and TiBrid SA Angled Screwdrivers (30°, 45°, 60° angles). Models include 17-5A-DV45, 17-5A-DV60, 00843511122041, 00843511122058, 00843511122065. Quantity: 15 units. Distribution: US Nationwide in AZ, CA, NJ, NV, OK, WA. Status: Active recall. Recall date: 2024-07-15.
No specific injuries or incidents are detailed in the provided data.
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