- Recalling firm
- Orthofix U.S. LLC
- 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
- Affected products (lot / model / serial)
- All Lots; GTIN# 18032568866681
- Units affected
- 32 units
- Distribution pattern
- 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
- Firm location
- Lewisville, TX, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2731-2026
- Recall initiated
- June 10, 2026
- FDA classification date
- July 14, 2026
- FDA report date
- July 22, 2026
- FDA event ID
- 99225
- Last updated on HTM Vibe
- July 28, 2026