Class III U.S. Food and Drug Administration

Orthofix U.S. LLC Brand Name: Firebird" SI Fusion System Product Name: Firebird" SI recall: Labeling contains claims that are not consistently present

Recall published 10 months ago

Labeling contains claims that are not consistently present.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Labeling contains claims that are not consistently present.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0894-2026
Published
December 17, 2025
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Orthofix U.S. LLC
Product type
Medical devices
Units affected
19431
Distribution
Nationwide
Made in
United States
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

Products covered by this recall

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

Check your product

The notice names 21 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

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

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Orthofix U.S. LLC — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Orthofix U.S. LLC — 3451 Plano Pkwy, Lewisville, TX, 75056-9453

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Orthofix U.S. LLC medical devices recalled?

Labeling contains claims that are not consistently present. Labeling contains claims that are not consistently present.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 18257200140084, 18257200140091, 18257200140107; lot code UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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