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FDA-Device2025-12-17Class IIIMISBRANDING

Orthofix FIREBIRD SI Fusion System screws recalled for inconsistent labeling claims

Orthofix
FALSE CLAIMSNationwide distribution

Contact Orthofix about FIREBIRD SI screw labeling

Orthofix U.S. LLC is recalling FIREBIRD SI Fusion System screws (multiple sizes, catalog numbers 18-1025SP through 18-2070SP) because the product labeling contains claims that are not consistently present across all units. The issue affects 19,431 screws distributed nationwide and internationally.

  • If you are a healthcare provider or facility, contact Orthofix U.S. LLC for further instructions.
  • Do not discard devices without guidance from Orthofix or your regulatory authority.
  • Verify your product serial numbers or UDI codes against the recalled lot numbers if you have these devices in stock.
Hazard

Labeling contains claims that are not consistently present.

Sold states
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.
Affected count
19431
Manufactured in
3451 Plano Pkwy, N/A, Lewisville, TX, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0894-2026

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