Orthofix U.S. LLC 2026-07-22 Health serious FDA
Health · FDA · Recall #FDA-Z-2729-2026
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral… Recall
Issued July 22, 2026 · Orthofix U.S. LLC
In July 2026, Orthofix U.S. LLC recalled the Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral…, a serious health recall reported by the FDA.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Orthofix U.S. LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Orthofix U.S. LLC
- Category
- Health
- Recall date
- July 22, 2026
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-2729-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Orthofix U.S. LLC has 1 recall in our database.
- We're tracking 3,673 Health recalls in our database.
- This is the 453rd Health recall we've logged in 2026.