Omnia Medical TiBrid Fusion Device Screwdrivers Recalled for Instrument Failure
Omnia Medical is recalling 15 units of TiBrid Stand Alone Intervertebral Body Fusion Device screwdrivers due to failure of fusion system instruments in the field. Units were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall for surgical fusion system instruments. No injuries or hospitalizations have been reported; however, failure of surgical fusion instruments poses a significant risk of harm to patients during spinal fusion procedures.
Plain-English summary
Omnia Medical is recalling 15 units of the TiBrid Stand Alone Intervertebral Body Fusion Device, specifically the TiBrid SA Angled Screwdrivers (30, 45, and 60 degree angles), due to failure of fusion system instruments reported in the field.
The affected devices were distributed nationwide to medical facilities in Arizona, California, New Jersey, Nevada, Oklahoma, and Washington. The recalled model numbers are 17-5A-DV45 and 17-5A-DV60, with Universal Device Identifiers (UDI) 00843511122041, 00843511122058, and 00843511122065.
Patients and healthcare providers who have received or used these instruments should contact Omnia Medical for further guidance and instructions regarding the affected devices.
The recalled product
- Product
- TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
- Manufacturer
- Omnia Medical
- Hazard
- instrument-failure
- surgical-device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model No. 17-5A-DV45
- 17-5A-DV60
- UDI: 00843511122041
- 00843511122058
- 00843511122065.
Distribution
Distributed nationwide across the United States.
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