Recall Z-2730-2026 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Orthofix U.S. LLC
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
| Date | Jul 14, 2026 (initiated Jun 10, 2026) |
| Status | Open, Classified |
| 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 |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 19 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113770 | ORTHOFIX GALAXY FIXATION SYSTEM Orthofix Srl, Sep 4, 2012 |