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Orthofix U.S. LLC

13 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/t recall (Z-2729-2026)Orthofix U.S. LLC2026-07-14
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixa recall (Z-2730-2026)Orthofix U.S. LLC2026-07-14
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/tra recall (Z-2731-2026)Orthofix U.S. LLC2026-07-14
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/tr recall (Z-2732-2026)Orthofix U.S. LLC2026-07-14
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer Syste recall (Z-0891-2026)Orthofix U.S. LLC2025-12-11
Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog recall (Z-0892-2026)Orthofix U.S. LLC2025-12-11
Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/ recall (Z-0893-2026)Orthofix U.S. LLC2025-12-11
Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Cata recall (Z-0894-2026)Orthofix U.S. LLC2025-12-11
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Nu recall (Z-0895-2026)Orthofix U.S. LLC2025-12-11
Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System recall (Z-0896-2026)Orthofix U.S. LLC2025-12-11
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The fo recall (Z-0478-2026)Orthofix U.S. LLC2025-11-07
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP recall (Z-2555-2025)Orthofix U.S. LLC2025-09-11
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, imp recall (Z-1432-2025)Orthofix U.S. LLC2025-03-21

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Every clearance here is in the API, with alerts when new ones post.