Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device
FDA device recall Z-2732-2026 · posted 2026-07-14 · Open, Classified
Recall details
- 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
- Action taken
- On June 8, 2026, Orthofix issued a Urgent Medical Device Recall Notification, via E.Mail. Orthofix asked consignees to take the following actions: 1.Discontinue use of the affected product lots immediately. 2.Immediately examine your inventory and quarantine any affected product and return them to Orthofix. 3. Complete the attached response form and return it to Orthofix. 4. This notice should be shared with all relevant personnel within your organization and forwarded to any other organization or facility where potentially affected devices may have been transferred.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- KTT
- Quantity affected
- 62 units
- Distribution
- 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
- Date initiated
- 2026-06-10
- Date posted
- 2026-07-14
- Location
- Lewisville, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHOFIX GALAXY FIXATION SYSTEM (K113770) | Orthofix Srl | 2012-09-04 |