Z-2731-2026Class II

Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external...

Name: Z-2731-2026 Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external...
Creator: Orthofix U.S. LLC
Published: 2026-06-10
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2026-06-10 / Open, Classified / root cause: labeling and UDI

FDA source

Orthofix U.S. LLC began a recall of Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device on 2026-06-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2731-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-10
Posted: 2026-07-14
Recalling firm: Orthofix SRL
Product: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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
Root cause tag: labeling and UDI
FDA 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 in commerce: 32 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
Product codes and lots: All Lots; GTIN# 18032568866681

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2731-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2729-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-14
Z-2730-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-14
Z-2731-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-14
Z-2732-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-22	2026-07-14

Product code KTT

K113770Class IIOrthofix Galaxy Fixation SystemOrthofix Srl / cleared 2012-09-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)