HIGH

Omnia Medical Recalls Intervertebral Fusion Device Over Safety Hazard

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.

Quick Facts at a Glance

Recall Date
July 15, 2024
Hazard Level
HIGH
Brand
Omnia Medical
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Failure of fusion system instruments in the field.

What You Should Do

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

Product Details

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 Hazard

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.

Reported Incidents

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.

What to Do

Patients and healthcare providers should stop using the device immediately. Contact Omnia Medical or your healthcare provider for further instructions on returning the product.

Contact Information

For more information, contact Omnia Medical via telephone. Additional details are available at the FDA recall notice.

Key Facts

  • 15 units recalled
  • Models: 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5
  • Distributed in AZ, CA, NJ, NV, OK, WA
  • Stop using immediately
  • Contact Omnia Medical for instructions

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Model No. 17-5A-AWL3
17-5A-AWL4
17-5A-AWL5
UDI: 00843511113056
00843511122287
+1 more
Affected States
ALL
Report Date
September 17, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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