Orthofix U.S. LLC recalls Orthofix MINIRAIL
- Recalling company
- Orthofix U.S. LLC
- Product
- Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
- Reason
- Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 10, 2026
- Reported
- Jul 22, 2026
- Distribution
- US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None
- Status
- Ongoing
- Quantity
- 48 units
- Lot / codes
- All Lots; GTIN# 18032568866636;
- Company location
- Lewisville, TX
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2729-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2729-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.