Orthofix U.S. LLC: 6 recalls on record

Recalls filed with 1 agency: FDA (6).

First recall on record: April 2, 2025. Most recent: July 22, 2026.

Risk classification: Class II: 5 · Class III: 1

Most recent recalls

DateAgencyProduct
July 22, 2026FDAOrthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/t…Z-2731-2026
July 22, 2026FDAOrthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/…Z-2732-2026
July 22, 2026FDAOrthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fi…Z-2730-2026
July 22, 2026FDAOrthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic…Z-2729-2026
December 17, 2025FDABrand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog…Z-0895-2026
April 2, 2025FDAOrthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, im…Z-1432-2025

Questions about this company

How many recalls does Orthofix U.S. LLC have?
Recalert has 6 U.S. recalls on record for Orthofix U.S. LLC, published between April 2, 2025 and July 22, 2026.
What was the most recent Orthofix U.S. LLC recall?
FDA recall Z-2731-2026, published July 22, 2026: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Which agencies have handled Orthofix U.S. LLC recalls?
Orthofix U.S. LLC appears as the recalling firm in recalls from: FDA (6).

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