OVERLOOKED

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Class IIOngoing

Orthofix U.S. LLC recalls 4 products

Recall date · record updated Jul 22, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Orthofix U.S. LLC
Reason
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
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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
Where
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, Wisconsin
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99225…

Products (4)

  1. Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device

    Codes/lots: All Lots; GTIN# 18032568866636;Quantity: 48 unitsRecall no. Z-2729-2026Class II

  2. Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device

    Codes/lots: All Lots/GTIN# 18032568866650Quantity: 19 unitsRecall no. Z-2730-2026Class II

  3. Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device

    Codes/lots: All Lots; GTIN# 18032568866681Quantity: 32 unitsRecall no. Z-2731-2026Class II

  4. Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device

    Codes/lots: All Lots; GTIN# 18032568866711Quantity: 62 unitsRecall no. Z-2732-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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