Orthofix U.S. LLC recalls
12 recalls filed under Orthofix U.S. LLC. The most recent was published July 22, 2026.
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Class II · 3 months ago
Orthofix Minirail, Short, Lengthener REF: M103 recall: Unilateral external fixation devices may be incorrectly labeled. Minirail
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail…
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Class II · 3 months ago
Orthofix Minirail, Articulated, Fixator, Vertical Axis REF: M122 recall: Unilateral external fixation devices may be incorrectly labeled. Minirail
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail…
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Class II · 3 months ago
Orthofix Articulated Minirail Fixator Horizontal Axis REF: M111 recall: Unilateral external fixation devices may be incorrectly labeled. Minirail
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail…
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Class II · 3 months ago
Orthofix Minirail, Standard Lengthener Model/ recall: Unilateral external fixation devices may be incorrectly labeled. Minirail
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail…
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Class III · 10 months ago
Orthofix U.S. LLC Brand Name: Forza" PTC Spacer System Product Name: Forza" PTC Spacer recall: Labeling contains claims that are not consistently present
Labeling contains claims that are not consistently present.
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Class III · 10 months ago
Orthofix U.S. LLC Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA recall: Labeling contains claims that are not consistently present
Labeling contains claims that are not consistently present.
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Class III · 10 months ago
Orthofix U.S. LLC Brand Name: Firebird" SI Fusion System Product Name: Firebird" SI recall: Labeling contains claims that are not consistently present
Labeling contains claims that are not consistently present.
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Class III · 10 months ago
Orthofix U.S. LLC Brand Name: Construx" Mini PTC Spacer System Product Name: Construx" recall: Labeling contains claims that are not consistently present
Labeling contains claims that are not consistently present.
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Class III · 10 months ago
Orthofix U.S. LLC Brand Name: Construx" Mini Ti Spacer System Product Name: Construx" recall: Labeling contains claims that are not consistently present
Labeling contains claims that are not consistently present.
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Class III · 10 months ago
Orthofix U.S. LLC Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer recall: Labeling contains claims that are not consistently present
Labeling contains claims that are not consistently present.
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Class II · 11 months ago
Orthofix U.S. LLC Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal recall: Polyaxial screws do not meet performance standards
Polyaxial screws do not meet performance standards.
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Class II · 1+ years ago
Orthofix U.S. LLC Pillar SA Ti, Sterile, 37mm x 28mm x 18mm , 20-degrees recall: A 37 mm implant width intervertebral body fusion device has a labeling
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…
About this page
Orthofix U.S. LLC appears here because a federal agency named it as the recalling firm or the brand on the label. A recall is not a judgement about everything the company sells — it covers only the lot codes and models listed in each notice.