Omnia Medical recalled 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device SA Angled Punch Awl. The recall covers models 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5 with UDI 00843511113056 and 00843511122287/22294. The hazard is failure of fusion system instruments in the field. Consumers should stop use and follow 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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The TiBrid device is used in spinal fusion procedures and relies on specialized instruments for operation.
The instruments used with the fusion device can fail in the field, potentially compromising the procedure.
This recall is not described as part of a broader industry pattern in the provided data.
Direct impact on surgeons and patients; potential procedure disruption and need for reoperation depending on instrument failure.
FDA recall page linked in data; manufacturer recall instructions
Actions are immediate; refunds/replacements depend on Omnia Medical processing
Keep recall notification, model and UDI references, hospital communications, and any instrument failure reports
Product: TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl. Models: 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5. UDI: 00843511113056, 00843511122287, 00843511122294. Quantity: 15 units. Distribution: US nationwide in AZ, CA, NJ, NV, OK, WA. Distributor/brand: Omnia Medical.
No injuries or incidents have been reported.
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