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Orthofix U.S. LLC

Orthofix U.S. LLC Recalls

All product recalls associated with Orthofix U.S. LLC.

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Recall Summary

Total Recalls

9

Past Year

9

Class I (Serious)

0

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

FIREBIRD SI Fusion System (Orthofix) – inconsistent labeling (2025)

Labeling contains claims that are not consistently present.

FDANov 3, 2025Nationwide• Orthofix U.S. LLC

CONSTRUX Mini Ti Spacer System (Orthofix) – inconsistent labeling (2025)

Labeling contains claims that are not consistently present.

FDANov 3, 2025Nationwide• Orthofix U.S. LLC

Brand Name: Forza" Ti Spacer System Product Name: Forza" ... (Orthofix U.S. LLC) – labeling contains claims that are not... (2025)

Labeling contains claims that are not consistently present.

FDANov 3, 2025Nationwide• Orthofix U.S. LLC

Pillar SA PTC Spacer System (Orthofix) – inconsistent labeling (2025)

Labeling contains claims that are not consistently present.

FDANov 3, 2025Nationwide• Orthofix U.S. LLC

FORZA PTC Spacer System (Orthofix) – inconsistent labeling (2025)

Labeling contains claims that are not consistently present.

FDANov 3, 2025Nationwide• Orthofix U.S. LLC

Brand Name: CONSTRUX" Mini PTC Spacer System Product Name... (Orthofix U.S. LLC) – labeling contains claims that are not... (2025)

Labeling contains claims that are not consistently present.

FDANov 3, 2025Nationwide• Orthofix U.S. LLC

Virata Preassembled Polyaxial Screw (Orthofix) – Performance Standard Failure (2025)

Polyaxial screws do not meet performance standards.

FDASep 19, 2025Nationwide• Orthofix U.S. LLC

PILLAR SA Ti Implant (Orthofix) – Labeling Discrepancy (2025)

A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.

FDAJun 24, 2025Nationwide• Orthofix U.S. LLC

Orthofix Pillar SA Spacer (Orthofix) – Mislabeled Height (2025)

The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.

FDAFeb 20, 2025Nationwide• Orthofix U.S. LLC