Spinal fusion punch awl instruments recalled due to field failure
Omnia Medical is recalling the TiBrid Stand Alone spinal fusion punch awl instruments due to failure in the field. The recall involves 15 units distributed in Arizona, California, New Jersey, Nevada, Oklahoma, and Washington.
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: FDA Class II recall with no reported injuries or illnesses. The hazard (instrument failure during spinal fusion procedures) represents a potential risk of serious harm, warranting a High severity score per the rubric.
Plain-English summary
Omnia Medical is recalling the TiBrid Stand Alone Intervertebral Body Fusion Device SA Angled Punch Awl. The affected instruments are available in 30-degree, 45-degree, and 60-degree angles. The recall involves 15 units distributed in Arizona, California, New Jersey, Nevada, Oklahoma, and Washington.
The devices are being recalled because the fusion system instruments are failing in the field during clinical use. The affected model numbers are 17-5A-AWL3, 17-5A-AWL4, and 17-5A-AWL5. The corresponding UDI codes are 00843511113056, 00843511122287, and 00843511122294.
Healthcare providers and facilities that have received these instruments should discontinue use immediately and contact Omnia Medical for further instructions regarding product return or replacement.
The recalled product
- Product
- TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
- Manufacturer
- Omnia Medical
- Hazard
- device-malfunction
- instrument-failure
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 (6)
- Model No. 17-5A-AWL3
- 17-5A-AWL4
- 17-5A-AWL5
- UDI: 00843511113056
- 00843511122287
- 00843511122294.
Distribution
Distributed nationwide across the United States.
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