Recall Z-2730-2026
Orthofix U.S. LLC · initiated June 10, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device
Codes / lots: All Lots/GTIN# 18032568866650
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
FDA-determined cause: Process change control
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.
Details
- Recall number
- Z-2730-2026
- Initiated
- June 10, 2026
- Posted by FDA
- July 14, 2026
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- 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
- Recalling firm
- Orthofix U.S. LLC, Lewisville, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2729-2026 Class II | Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | 06/10/2026Open, Classified |
| Z-2731-2026 Class II | Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | 06/10/2026Open, Classified |
| Z-2732-2026 Class II | Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | 06/10/2026Open, Classified |