Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111 — Class II medical device recall Z-2731-2026
Ongoing recall by Orthofix U.S. LLC, reported 2026-07-22, distributed in AZ, CA, CO, CT, FL, GA, ID, IL…. Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M
| Recall number | Z-2731-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix U.S. LLC, Lewisville, TX, United States |
| Recall initiated | 2026-06-10 |
| Classified | 2026-07-14 |
| Reported by FDA | 2026-07-22 |
| Distributed | 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 |
| Quantity | 32 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 18032568866681 |
| Model numbers | M111 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2731-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.