Safety Alert: Class II: Failure of fusion system instruments in the field.
healthClass IIRecalled on Sep 17, 2025
TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
🔢 15 units
Sold At: Omnia Medical(US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.)
Recall #: FDA-DEVICE-Z-2557-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Model No. 17-5A-DV45, 17-5A-DV60; UDI: 00843511122041, 00843511122058, 00843511122065.
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Summary
Failure of fusion system instruments in the field.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Omnia Medical for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.