Lower riskMedical device recall · FDA · Published June 10, 2026
Orthof: MINIRAIL Standard Lengthener Model M101 Mislabeled - Risk of Incorrect Use
Orthofix recalls MINIRAIL Standard Lengthener Model M101 due to mislabeling risks incorrect use. Check your device's model number against the recall list.
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
Take action
Contact the company
📍Recalling firmOrthofix U.S. LLC3451 Plano Pkwy · Lewisville, TX 75056-9453
“Orthof: MINIRAIL Standard Lengthener Model M101 Mislabeled - Risk of Incorrect Use.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49018-orthof-minirail-standard-lengthener-model-m101-mislabeled-risk-of-incorrect. Based on FDA recall #Z-2729-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2729-2026%22&limit=1).
Orthofix U.S. LLC voluntarily recalled its MINIRAIL, STANDARD LENGTHENER external fixation devices on June 10, 2026, according to the FDA. The agency announced the Class II recall due to incorrect labeling of model numbers.
How to tell if you have it
Brand: Orthofix
Product: MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101
UPC: 18032568866636
The hazard
The unilateral external fixation devices may be incorrectly labeled. Specifically, Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111.
Context
GovInfoNow's records show Orthofix U.S. LLC has had four other recalls since Feb. 20, 2025. Recent brand recalls include the Nov. 3, 2025 Pillar SA PTC Spacer System Recall for labeling inconsistencies and the Sept. 19, 2025 Orthofix Virata Preassembled Polyaxial Screws recall due to performance issues. Other recent recalls of similar products include the Feb. 18, 2026 XTANT Medical Xpress Pedicle Screw System (incorrect labeling risk), the May 22, 2026 W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall (incorrect labeling risk), and the April 3, 2026 Grace Medical recalls Stapes Prosthesis due to incorrect labeling.
How to tell if you have this one
Check the model number on your device. The recalled model is M101, which may be labeled as M103, M122, or M111. The product was sold with GTIN# 18032568866636.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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
Recall number
Product, codes & lots
Quantity
Z-2729-2026
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device; All Lots; GTIN# 18032568866636;
Look for the model number on your device to confirm if it matches the recalled M101 or mislabeled versions.
Where it went and when
Where it was distributed
Distributed in 26 states.
Listed by the agency
Not listed
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Michigan, Mississippi, Missouri, Montana, New York, North Carolina, Ohio, Oregon, South Carolina, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2729-2026 (June 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2729-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.