FDAFDA recall Z-2731-2026 · Jul 22, 2026
Orthofix U.S. LLC: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111 recall
Recall found
Product
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Reason for recall
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
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- All Lots; GTIN# 18032568866681
- Quantity
- 32 units
- 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
- Recalling firm
- Orthofix U.S. LLC, Lewisville, TX
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-10
Source: openFDA enforcement record Z-2731-2026 · search recall number Z-2731-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.