What is being recalled?

The I.T.S. LRS Orthopedic System, including distal femur plates and tibia plates, is recalled due to updated MRI safety testing showing higher RF-induced heating under certain MRI conditions.

Why is this recall being issued?

Updated MRI safety testing indicates higher temperature increases when exposed to MRI fields than what was stated in the Instructions for Use.

Are there injuries related to this recall?

No injuries or incidents have been reported to date.

Who is affected by this recall?

Patients with the I.T.S. LRS Distal Femur Plate or Proximal Lateral/Medial Tibia Plates implanted in the United States.

How do I know if my device is included?

Compare the article numbers on labeling (21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13, 21321-7, 21321-12, 21322-7, 21322-12, 21325-4, 21325-7) to the recall notice.

What should I do if I had surgery with this device?

Contact your surgeon or healthcare provider for guidance and follow the manufacturer’s recall instructions.

Can I undergo MRI exams with this device?

MRI should not be performed unless explicitly cleared by your clinician and the device manufacturer.

Where can I get more information?

Refer to the recall notice and FDA enforcement page linked in the notice; contact I.T.S. GmbH for instructions.

Will I get a refund or replacement?

Remedies may vary by case; contact the manufacturer for recall-specific options.

How long will the remediation take?

Repair or replacement timelines for medical devices vary; follow manufacturer guidance and your healthcare provider.

What documentation should I keep?

Keep labeling, article numbers, lot numbers, and all recall communications.

If I don’t respond quickly, what should I do?

Document your attempts to contact the manufacturer and your clinician; escalate through the recall channel if needed.

Who can report adverse events?

Patients or clinicians can report through the appropriate regulatory channels if injuries occur.

HIGHJanuary 23, 2026

I.T.S. GmbH LRS Orthopedic System Recall: 176 Units for MRI Heating Risk (2026)

ITS GmbH recalled 176 units nationwide in the United States after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions. The issue could cause burns during MRI exposure. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

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

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

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About This Product

The I.T.S. LRS is an orthopedic implant system used in complex knee and leg reconstructions. It includes distal femur and tibia locking plates used in fracture repair.

Why This Is Dangerous

The device may experience higher RF-induced heating during MRI, which can cause tissue damage or burns in the area of the implant.

Industry Context

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

Real-World Impact

The recall requires immediate cessation of use. Patients with the device should avoid MRI unless cleared. The recall may affect surgical planning and postoperative imaging for affected patients.

Practical Guidance

How to identify if yours is affected

Review labeling for article numbers 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13, 21321-7, 21321-12, 21322-7, 21322-12, 21325-4, 21325-7
Compare to your device labeling and lot numbers shown in the recall notice.
Check if the device is implanted and requires follow-up.

Where to find product info

Labeling on the device packaging and IFU. FDA recall page linked in the notice.

What timeline to expect

Recall notices and guidance are issued by manufacturer; remediation timelines vary. Immediate action is required for MRI safety.

If the manufacturer is unresponsive

Document attempts to contact I.T.S. GmbH.
Consult your surgeon for interim imaging and management.
Escalate to regulatory authorities if there is no response within a reasonable period.

How to prevent similar issues

Verify MRI compatibility before any imaging after implantation.
Ask supplier about MRI safety with implants.
Maintain updated IFU for implanted devices.

Documentation advice

Keep recall notices, labeling, article numbers and lot numbers, and all correspondence with surgeon and manufacturer.

Product Details

Group 1: DFL Distal Femur Locking Distal Femur Plate — Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. Group 2: PTL Proximal Lateral Tibia Plate — Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. Group 3: PTL Proximal Medial Tibia Plate — Article Numbers: 21325-4, 21325-7. Quantity: 176 units. Sold nationwide in the United States in the states listed in the recall notice. Sold date range not specified. Manufacturer: I.T.S. GmbH. Remedy: Stop using the device immediately. Contact I.T.S. GmbH or healthcare provider for instructions.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

176 units recalled
MRI safety testing found higher RF-induced heating
Article numbers span 21301-5 through 21302-13 for distal femur plates and 21321-12 through 21325-7
No injuries reported
Immediate stop-use guidance
US nationwide distribution in multiple states

View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

BURN

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeOrthopedic Locking Reconstruction System

Product Details

Jan 23, 2026

I.T.S. GmbH

Updated MRI