Omnia Medical recalled 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device on July 15, 2024. The recall follows reports of failure of fusion system instruments in the field. Healthcare providers and patients must stop using the device immediately.
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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The recalled product includes sizes of 30 degree, 45 degree, and 60 degree. Model numbers include 17-5A-AWL3, 17-5A-AWL4, and 17-5A-AWL5. The devices were distributed nationwide in Arizona, California, New Jersey, Nevada, Oklahoma, and Washington.
The recall concerns a failure of the fusion system instruments, posing a high risk to patients. This failure can lead to ineffective surgical outcomes and potential harm.
The recall does not specify any reported injuries or deaths related to the devices. However, the potential for serious complications exists due to the instrument failure.
Patients and healthcare providers should stop using the device immediately. Contact Omnia Medical or your healthcare provider for further instructions on returning the product.
For more information, contact Omnia Medical via telephone. Additional details are available at the FDA recall notice.
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