HIGH

Omnia Medical Recalls Intervertebral Fusion Devices Over Hazard

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.

Quick Facts at a Glance

Recall Date
July 15, 2024
Hazard Level
HIGH
Brand
Omnia Medical
Category
Health & Personal Care
Sold At
Multiple Retailers
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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

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 Hazard

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.

Reported Incidents

Currently, there are no specific reports of injuries or incidents associated with this recall. The potential for serious complications remains a concern for users.

What to Do

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

Contact Information

For more details, call Omnia Medical or visit their website. The recall notice can also be found at the FDA enforcement report link.

Key Facts

  • 15 units recalled
  • Affected states: AZ, CA, NJ, NV, OK, WA
  • Potential device failure risk
  • Immediate cessation of use required

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

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

Product Classification

Product Details

Model Numbers
17-5A-DV45
17-5A-DV60
00843511122041
00843511122058
00843511122065
Affected States
ALL
Report Date
September 17, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Novo Nordisk Recalls Wegovy Injection Due to Contamination Risk

Novo Nordisk recalled Wegovy (semaglutide) Injection on December 19, 2025, due to hair found in a prefilled syringe. The recall affects products distributed nationwide in the United States. Consumers should stop using the product immediately and contact their healthcare provider.

Wegovy
Presence of
Read more
HIGH

Zydus Pharmaceuticals Recalls TraZODONE Tablets Over Defects

Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Zydus Pharmaceuticals
Failed Tablet/Capsule
Read more
HIGH

Merck Recalls Noxafil Oral Suspension Due to Metal Contamination

Merck Sharp & Dohme LLC recalled 845 kits of Noxafil Powdermix on December 12, 2025. The recall follows the discovery of potential metal particulates in the product. Consumers should stop using the medication immediately and contact their healthcare provider for further guidance.

NOXAFIL
Presence of
Read more
HIGH

Merck Emend Recalled Due to Potential Metal Contamination

Merck Sharp & Dohme LLC recalled 3 single-dose kits of Emend (aprepitant) on December 12, 2025. The recall stems from the potential presence of metal particulates in the medication. Consumers should immediately stop using the product and contact their healthcare provider for guidance.

EMEND
Presence of
Read more
HIGH

Beaver-Visitec Recalls Laser and Endoscopy System Over Safety Hazard

Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.

Beaver-Visitec International
Manufacturing deviation
Read more