Reported Sep 17, 2025 · Ongoing
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
Omnia Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Omnia Medical · 6 Canyon Rd Ste 300 · Morgantown, WV · 26508-9232
Is this the product you have?
- TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl
- Sizes
30 degree45 degree and 60 degree
- Lot codes and dates
Model No. 17-5A-AWL317-5A-AWL417-5A-AWL5
- UDI
008435111130560084351112228700843511122294
- Amount recalled
- 15 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Failure of fusion system instruments in the field.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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