FDAHealthJuly 15, 2024
Omnia Medical — TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
⚠️ Failure of fusion system instruments in the field.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 15, 2024
US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
What's affected?
- Product
- TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
- Brand
- Omnia Medical
- Lot code
- Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.
Additional details
Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 15 units.
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