Filing Flows › Orthofix Medical (OFIX) › Recalls, complaints & regulation
Orthofix Medical (OFIX): recalls and clinical trials
Orthofix Medical (OFIX) beyond its filings: 11 recalls in the last 12 months (14 in five years, 0 Class I); 7 active clinical trials.
Latest recalls
- 2026-07-22 · FDA device · Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
- 2026-07-22 · FDA device · Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
- 2026-07-22 · FDA device · Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
- 2026-07-22 · FDA device · Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
- 2025-12-17 · FDA device · 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; 38-20
- 2025-12-17 · FDA device · 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
- 2025-12-17 · FDA device · 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;
- 2025-12-17 · FDA device · 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
Orthofix Medical's latest quarter
Orthofix Medical, Q2 FY26: revenue $211M (+4% year over year), operating margin -3.9%, net loss $15.8M, operating cash flow −$6.2M. The chart follows the revenue to costs, profit and cash.
Questions
Has Orthofix Medical had any recalls?
14 recalls on file over five years from the FDA, CPSC and NHTSA; 11 in the last 12 months.
How many clinical trials does Orthofix Medical have?
7 active studies on ClinicalTrials.gov, 0 in phase 3.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.