FDA recall, , Moderate risk
Orthofix Minirail External Fixation Devices
Unilateral external fixation devices may be incorrectly labeled.
Summary by Recall Canary from the FDA notice
What happened
Orthofix U.S. LLC, of Lewisville, Texas, began a recall on June 10, 2026, of unilateral external fixation devices that may be incorrectly labeled. The affected products include Orthofix Minirail Standard Lengthener, Articulated Minirail Fixator Horizontal Axis, Articulated Minirail Fixator Vertical Axis, and Minirail Short Lengthener. Specific labeling includes Minirail M101 labeled as M103, M103 labeled as M101, and M122 labeled as M111.
The recall was added to the FDA's Enforcement Report and classified on July 14, 2026, and in the FDA's weekly enforcement report on July 22, 2026.
The devices were distributed in the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin, with no distribution outside the U.S. The recall was initiated as a result of complaints.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Orthofix Minirail, Standard Lengthener Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
- UDI-DI
- 18032568866636
- Lot code
- All Lots
Orthofix Articulated Minirail Fixator Horizontal Axis REF: M111, Unilateral orthopedic/trauma external fixation device
- UDI-DI
- 18032568866681
- Lot code
- All Lots
Orthofix Minirail, Articulated, Fixator, Vertical Axis REF: M122, Unilateral orthopedic/trauma external fixation device
- UDI-DI
- 18032568866711
- Lot code
- All Lots
Orthofix Minirail, Short, Lengthener REF: M103, Unilateral orthopedic/trauma external fixation device
- UDI-DI
- 18032568866650
- Lot code
- All Lots/GTIN# 18032568866650
Recall details
- Company began the recall
- Sold in
- 26 states
US: Arizona California Colorado Connecticut Florida Georgia ID Illinois IN Louisiana MD Michigan Missouri Mississippi Montana North Carolina New York Ohio OR South Carolina South Dakota Texas Utah Virginia Washington Wisconsin OUS: None
- Company
- Orthofix U.S. LLCLewisville, Texas
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99225
- Recall numbers
- Z-2729-2026 to Z-2732-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
