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ORTHOFIX MODULSYSTEM recallZ-2731-2026 · Orthofix U.S. LLC · initiated Jun 10, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Orthofix U.S. LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process change control

What the company is doing

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.

Recall details

Recall number
Z-2731-2026
Status
Open, Classified
Initiated by the company
Jun 10, 2026
Posted by the FDA
Jul 14, 2026
Recalling firm
Orthofix U.S. LLC
Quantity
32 units
Product code
KTT
FDA submissions
K113770
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 description

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

Code information (models, lots, serial numbers)

All Lots; GTIN# 18032568866681

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K113770 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99225).

Sources and updates

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