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, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
🔢 15 units
Sold At: Omnia Medical(US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.)
Recall #: FDA-DEVICE-Z-2556-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.
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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.