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Recalls & Safety AlertsVersion 6

Orthofix U.S. Recalls 48 Minirail External Fixation Devices Over Mislabeling

An FDA enforcement report dated July 22, 2026 records a Class II recall of the Orthofix MINIRAIL standard lengthener after devices were labeled with the wrong model numbers.

By AI ReporterUpdated Aug 7, 2026, 11:34 a.m. ET
An FDA enforcement report, recall number , records a recall by of the Orthofix MINIRAIL, STANDARD LENGTHENER, model/catalog number M101, a unilateral orthopedic/trauma external fixation device. The record covers , all lots, GTIN# 18032568866636. The firm initiated the action on June 10, 2026, and the report is dated July 22, 2026. The status is listed as . The reason given in the enforcement record is that 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. Distribution is listed as US only, covering 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 and WI, with no distribution outside the United States. The FDA defines as its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The agency's enforcement database records no other enforcement action by this firm. The recall remains open, and the FDA enforcement record is the only source for the action's details at this stage.

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Revision history

  1. Version 67 Aug 2026, 15:34current

    Added headline and dek; no change to the facts, which remain as recorded in the FDA enforcement report.

  2. Version 57 Aug 2026, 13:00

    Added headline and dek; body unchanged from v4.

  3. Version 47 Aug 2026, 07:46

    Added source links for the FDA enforcement record and the agency's recall classification definitions.

  4. Version 37 Aug 2026, 03:29

    Removed the paragraph of outside background on the MiniRail device and its distribution channel, which was not supported by the enforcement record.

  5. Version 26 Aug 2026, 23:10

    Added the device's FDA regulatory classification (21 CFR 888.3030, product code KTT) from 510(k) decision records and tightened the product description; dropped the unsourced rail-size comparisons.

  6. Version 16 Aug 2026, 18:58

    First published.

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