Recall record at a glance
| Official record | Z-0894-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Ongoing |
| Recalling firm | Orthofix U.S. LLC |
| Report date | Dec 17, 2025 |
| Recall initiation date | Nov 3, 2025 |
| Quantity | 19431 |
| Location | Lewisville, TX, United States |
Official product description
Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI Screw; 18-1035SP 11mm X 35mm FIREBIRD SI Screw; 18-1040SP 11mm X 40mm FIREBIRD SI Screw; 18-1045SP 11mm X 45mm FIREBIRD SI Screw; 18-1050SP 11mm X 50mm FIREBIRD SI Screw; 18-1055SP 11mm X 55mm FIREBIRD SI Screw; 18-1060SP 11mm X 60mm FIREBIRD SI Screw; 18-1065SP 11mm X 65mm FIREBIRD SI Screw; 18-1070SP 11mm X 70mm FIREBIRD SI Screw; 18-2025SP 12mm X 25mm FIREBIRD SI Screw; 18-2030SP 12mm X 30mm FIREBIRD SI Screw; 18-2035SP 12mm X 35mm FIREBIRD SI Screw; 18-2040SP 12mm X 40mm FIREBIRD SI Screw; 18-2045SP 12mm X 45mm FIREBIRD SI Screw; 18-2050SP 12mm X 50mm FIREBIRD SI Screw; 18-2055SP 12mm X 55mm FIREBIRD SI Screw; 18-2060SP 12mm X 60mm FIREBIRD SI Screw; 18-2065SP 12mm X 65mm FIREBIRD SI Screw; 18-2070SP 12mm X 70mm FIREBIRD SI Screw
Why the product was recalled
Labeling contains claims that are not consistently present.
Distribution information
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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