Reported Dec 17, 2025 · Ongoing
Brand Name
Orthofix U.S. LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix U.S. LLC · 3451 Plano Pkwy · Lewisville, TX · 75056-9453
Is this the product you have?
Brand Name
20 of 20 products
| Model / number | Product as published |
|---|---|
11mm | 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 |
12mm | 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 |
- Lot codes and dates
- Lot CodeAll
- Lots/ UDI
18-1025SP 1825720014008418-1030SP 1825720014009118-1035SP 1825720014010718-1040SP 1825720014011418-1045SP 1825720014027518-1050SP 1825720014012118-1055SP 1825720014013818-1060SP 1825720014014518-1065SP 1825720014015218-1070SP 1825720014016918-2025SP 1825720014017618-2030SP 1825720014018318-2035SP 1825720014019018-2040SP 1825720014020618-2045SP 1825720014021318-2050SP 1825720014022018-2055SP 1825720014023718-2060SP 1825720014024418-2065SP 1825720014025118-2070SP 18257200140268
- Amount recalled
- 19431
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Labeling contains claims that are not consistently present.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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