FDA Medical devices recall ·
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl… recall
- Recall number
- Z-2556-2025
- Date
- (initiated July 15, 2024)
- Company / brand
- Omnia Medical
6 Canyon Rd Ste 300, Morgantown, WV, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 15 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
Why was it recalled?
Failure of fusion system instruments in the field.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.
Distribution
US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
States: Arizona California New Jersey Nevada Oklahoma Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2556-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.