FDA Medical devices recall ·
Orthofix MINIRAIL, STANDARD LENGTHENER Model recall
- Recall number
- Z-2729-2026
- Date
- (initiated June 10, 2026)
- Company / brand
- Orthofix U.S. LLC
3451 Plano Pkwy, Lewisville, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 48 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All Lots; GTIN# 18032568866636;
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: Arizona California Connecticut Florida Georgia Illinois Maryland Michigan Missouri Mississippi Montana North Carolina New York South Carolina South Dakota Texas Utah Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2729-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.