Orthofix U.S. LLC: 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 Scre

Hazard

Labeling contains claims that are not consistently present.

Details from the source

Reason for recall: Labeling contains claims that are not consistently present. Distribution: 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. Quantity: 19431 Lot/code info: Lot Code: All Lots/ UDI: 18-1025SP 18257200140084; 18-1030SP 18257200140091; 18-1035SP 18257200140107; 18-1040SP 18257200140114; 18-1045SP 18257200140275; 18-1050SP 18257200140121; 18-1055SP 18257200140138; 18-1060SP 18257200140145; 18-1065SP 18257200140152; 18-1070SP 18257200140169; 18-2025SP 18257200140176; 18-2030SP 18257200140183; 18-2035SP 18257200140190; 18-2040SP 18257200140206; 18-2045SP 18257200140213; 18-2050SP 18257200140220; 18-2055SP 18257200140237; 18-2060SP 18257200140244; 18-2065SP 18257200140251; 18-2070SP 18257200140268

UPC codes

18257200140084, 18257200140091, 18257200140107, 18257200140114, 18257200140275, 18257200140121, 18257200140138, 18257200140145, 18257200140152, 18257200140169, 18257200140176, 18257200140183, 18257200140190, 18257200140206, 18257200140213, 18257200140220, 18257200140237, 18257200140244, 18257200140251, 18257200140268

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.