What is being recalled and why?

The I.T.S Straight Plate with Angular Stability devices are recalled due to MRI safety concerns. Updated testing showed higher RF-induced temperature increases under certain MRI conditions than what the Instructions for Use previously indicated.

Which specific products are affected?

Multiple article numbers cover forearm plates and straight plates in various thicknesses and configurations. See the recall notice for the full list of article numbers.

Are there any reported injuries?

No injuries or incidents have been reported to date.

Who is affected by this recall?

Patients with the affected I.T.S. Straight Plate with Angular Stability implants and the healthcare providers who manage them.

What should I do if I have one of these implants?

Stop using the device and contact your healthcare provider for guidance. Follow the manufacturer's recall instructions for next steps.

How do I know if my device is affected?

Check the article numbers on your device labeling or packaging against the recalled article numbers listed in the notice.

What about MRI exams?

The recall is related to MRI heating risk. Do not undergo MRI with the affected device unless your clinician determines it is safe.

Is there a remedy or replacement?

Remedy involves following the manufacturer’s recall instructions. Replacement options may be discussed with your clinician.

How will I be notified?

Notification is via email per the recall notice from ITS GmbH.

Where can I get more information?

Refer to the FDA enforcement page linked in the recall notice and contact ITS GmbH for instructions.

HIGHJanuary 23, 2026

ITS GmbH Recalled 510 I.T.S Straight Plate with Angular Stability Over MRI Heating Risk (2026)

ITS GmbH recalled 510 units of the I.T.S Straight Plate with Angular Stability after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions. The recall covers multiple article numbers across forearm and straight plates and distributions nationwide in the United States. No injuries or incidents have been reported at this time. Healthcare providers andpatients

Quick Facts at a Glance

Recall Date: January 23, 2026
Hazard Level: HIGH
Brand: I.T.S. GmbH
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL, PREGNANT, ELDERLY

Hazard Information

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact I.T.S. GmbH or your healthcare provider for instructions. Notification method: E-Mail

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

About This Product

Orthopedic plates used to stabilize forearm fractures in surgical procedures. They come in multiple thicknesses and configurations, designed to be fixed to bone with screws.

Why This Is Dangerous

MRI exposure can cause heating of the implanted plate due to RF energy. This heating could pose a burn risk to surrounding tissue.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

The devices may require discontinuation of use and consultation with a clinician. Patients may need alternative stabilization methods or adjusted imaging plans.

Practical Guidance

How to identify if yours is affected

Identify if your device is among the recalled article numbers.
Check labeling or packaging for article numbers 21604-6, 21604-9, 21605-11, 21605-6, 21605-9, 21105-6, 21105-8, 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9, 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13, 21102-6, 21103-8, 21103-11, 21103-10, 21103-12, 21103-13, 21103-9.
Consult your surgeon or orthopedic specialist for confirmation.

Where to find product info

Refer to the manufacturer's recall notice and your device labeling for article numbers. Contact ITS GmbH via email for official instructions.

What timeline to expect

Official recall remediation timeline not specified. Follow manufacturer instructions and clinician guidance.

If the manufacturer is unresponsive

Document all communications.
Escalate to the hospital’s risk management or patient safety office if the manufacturer is slow to respond.

How to prevent similar issues

If purchasing implants in the future, verify MRI compatibility and safety testing in the IFU.
Consult clinicians about MRI safety before imaging.
Maintain copies of all recall communications and instructions.

Documentation advice

Keep the recall notice, correspondence with the manufacturer, and your clinician's guidance. Record article numbers and imaging plans.

Product Details

Product line: I.T.S Straight Plate with Angular Stability Distribution: US nationwide Units recalled: 510 Categories: Forearm Plate, Forearm Plate Curved, Forearm Plate Straight, Straight Compression Plate, Straight Plate (1.5mm, 2.0mm, 3.5mm, 4.5mm) Article numbers affected: 21604-6, 21604-9, 21605-11, 21605-6, 21605-9, 21105-6, 21105-8, 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9, 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13, 21102-6, 21103-8, 21103-11, 21103-10, 21103-12, 21103-13, 21103-8, 21103-9 Reason for recall: Updated MRI safety testing demonstrateshigher

Reported Incidents

No injuries or incidents have been reported.

Key Facts

510 units recalled
MRI safety testing updated showing higher RF heating
Multiple article numbers across forearm and straight plates
Distributed nationwide in the US and territories
No injuries reported to date

View Original Recall on FDA - Medical Devices

Browse More Recalls

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERALPREGNANTELDERLYCHILDRENINFANTS

Injury Types

BURNELECTRICAL

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeOrthopedic plate set (I.T.S. Straight Plate with Angular Stability)

Product Details

Jan 23, 2026

I.T.S. GmbH

Updated MRI