The Recall Desk

FDA (Devices) recall action 97862

Orthofix U.S. LLC recalled 6 products on 2025-12-17

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2025-12-17
Critical
1
Units
184,464

Why these products were recalled

Labeling contains claims that are not consistently present.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • ModerateFDA (Devices)··2025-12-17

    Sacroiliac fusion screws recalled over labeling claims not consistently present

    Orthofix U.S. is recalling 19,431 FIREBIRD SI Fusion System units because the labeling contains claims that are not consistently present.

    Product
    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; 18-1045S
    Category
    Distribution
    47 states
  • CriticalFDA (Devices)··2025-12-17

    Frozen surti undhiu mix recalled after testing positive for Salmonella

    Chetak New York is recalling Deep-brand frozen surti undhiu mix after the product tested positive for Salmonella. The FDA has classified the action as Class I.

    Product
    Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H; 38-1010
    Category
    Distribution
    47 states
  • ModerateFDA (Devices)··2025-12-17

    Titanium spinal spacers recalled over labeling claims not consistently present

    Orthofix U.S. is recalling 40,956 CONSTRUX Mini Ti Spacer System units because the labeling contains claims that are not consistently present.

    Product
    Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6006SP 12mm W X 12
    Category
    Distribution
    47 states
  • ModerateFDA (Devices)··2025-12-17

    PTC spacer implants recalled over labeling claims not consistently present

    Orthofix U.S. is recalling 13,317 Pillar SA PTC Spacer System units because the labeling contains claims that are not consistently present.

    Product
    Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14H, 7DEG PTC IMPLANT; 39-9016SP 33W X 28L X 16H, 7DEG PTC IMPLANT; 39-9018SP 33W X 28L X 18H, 7DEG
    Category
    Distribution
    47 states
  • ModerateFDA (Devices)··2025-12-17

    Mini PTC spacer implants recalled over labeling claims not consistently present

    Orthofix U.S. is recalling 61,977 CONSTRUX Mini PTC Spacer System units because the labeling contains claims that are not consistently present.

    Product
    Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L
    Category
    Distribution
    47 states
  • ModerateFDA (Devices)··2025-12-17

    Titanium spacer implants recalled over labeling claims not consistently present

    Orthofix U.S. is recalling 14,201 Forza Ti Spacer System units because the labeling contains claims that are not consistently present.

    Product
    Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP F
    Category
    Distribution
    47 states