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Orthofix MINIRAIL Standard Lengthener
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MEDICAL DEVICE RECALLMODERATE

Orthofix MINIRAIL Standard Lengthener

Orthofix recalls MINIRAIL Standard Lengthener (M101) over incorrect labeling.

What to do

Check your inventory for the affected Model/Catalog Number M101 and stop using any incorrectly labeled devices. Contact Orthofix U.S. LLC for instructions on returning or replacing the affected product.

Recalled
Listed
Updated
Recall No.
Z-2729-2026
Agency
FDA
Firm
Orthofix U.S. LLC
Recall ID
99225
Status
ONGOING

Why it was recalled

Orthofix is recalling its MINIRAIL Standard Lengthener, Model/Catalog Number M101, a unilateral external fixation device used in orthopedic and trauma procedures, because the devices may be incorrectly labeled.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DI
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device–Z-2729-202618032568866636
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device–Z-2731-202618032568866681
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device–Z-2732-202618032568866711
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device–Z-2730-202618032568866650
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation deviceAll Lots/GTIN# 18032568866650––
Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation deviceAll Lots–18032568866711
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation deviceAll Lots–18032568866681
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation deviceAll Lots–18032568866636

Where it was sold

Distributed in 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, and Wisconsin.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Labeling Error recalls

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Editorial summary by Recall Canary · summary updated 2026-09-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification