Omnia Medical recalled 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device on July 15, 2024. The recall affects devices distributed nationwide across six states due to potential failure of fusion system instruments. Patients and healthcare providers must stop using the devices immediately to avoid high-risk complications.
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
The recall involves the TiBrid Stand Alone Intervertebral Body Fusion Device and TiBrid SA Angled Screwdrivers in 30, 45, and 60 degree sizes. The affected model numbers include 17-5A-DV45, 17-5A-DV60, and UDI numbers 00843511122041, 00843511122058, and 00843511122065. These devices were distributed across Arizona, California, New Jersey, Nevada, Oklahoma, and Washington.
The recall stems from a failure of the fusion system instruments in the field. This defect poses a high risk of complications during surgical procedures, potentially leading to severe health issues for patients.
Currently, there are no specific reports of injuries or incidents associated with this recall. The potential for serious complications remains a concern for users.
Patients and healthcare providers should stop using the device immediately. Contact Omnia Medical or your healthcare provider for further instructions on the recall process.
For more details, call Omnia Medical or visit their website. The recall notice can also be found at the FDA enforcement report link.
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