What is being recalled and why?

The I.T.S. Screw System is recalled due to MRI safety concerns. Updated testing shows higher RF-induced heating under certain MRI conditions than described in the IFU, potentially causing burns.

Which products are affected by the recall?

A broad range of I.T.S. Cannulated cancellous screws, cannulated cortical screws, washers, and washer variants with listed article numbers are affected. See the recall notice for the full list.

Are there any injuries reported?

No injuries or incidents have been reported to date.

How can I identify if my implant is affected?

Check the article number on the device packaging or labeling against the recall list provided by ITS.

What should I do to get a remedy?

Contact ITS GmbH or your healthcare provider for instructions. Follow the recall notification method (email) for guidance on next steps.

How long does a remedy take?

Remedy timelines vary. Manufacturers typically provide refunds or replacements within several weeks to a couple of months depending on inventory and process.

Will I need to visit a hospital or clinic?

Healthcare providers should be involved in any further steps, including MRI risk assessments and potential device management.

What about MRI scanning with implants during the recall?

If MRI is required, consult with a healthcare provider and refer to the updated safety guidance in the recall notice.

Can I dispose of the device myself?

Do not dispose of the device. Follow the manufacturer’s recall instructions and coordinate with your clinician.

Where can I find more information?

Refer to the FDA enforcement recall page with recall number Z-1599-2026 and ITS communications for details.

What should I document for my records?

Save the recall notice, document article numbers checked, and record all communications with ITS and your healthcare provider.

HIGHJanuary 23, 2026

I.T.S. Screw System Recalled for MRI Heating Risk in 5,568 Units (2026)

Q: Should I stop using the recalled devices?

Yes. Stop using the device immediately and follow the recall instructions.

I.T.S. GmbH has recalled 5,568 units of the I.T.S. Screw System sold nationwide in the United States after MRI safety tests showed higher RF-induced temperature increases under some MRI conditions than the IFU outlined. The defect involves MRI RF heating that could burn patients. Patients and healthcare providers should stop using the device immediately and follow the 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. Screw System is an orthopedic implant system used in bone fixation. It includes cancellous and cortical screws and washers used in surgical procedures.

Why This Is Dangerous

MRI RF heating can raise temperatures at the implant site, creating a burn risk for patients undergoing MRI under certain conditions.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall requires stopping use of affected implants and contacting the manufacturer for guidance, with potential impacts on follow-up imaging and surgical planning.

Practical Guidance

How to identify if yours is affected

Review the article numbers listed in the recall cover.
Check the labeling and packaging for article numbers matching the recall list.
Compare with your implant inventory to identify affected devices.

Where to find product info

Article numbers appear on device packaging, labeling, or surgical documentation.

What timeline to expect

Remedy processing may take 4-6 weeks, depending on inventory and manufacturer actions.

If the manufacturer is unresponsive

Document all attempts to contact ITS and your clinician.
Escalate to hospital risk management or patient safety officials if the company is slow to respond.

How to prevent similar issues

Before surgery, confirm MRI compatibility of implants with the surgeon.
Ask for updated safety instructions if MRI is anticipated for a patient with implants.
Keep the recall documentation with patient records for future reference.

Documentation advice

Keep a copy of the recall notice, record all article numbers checked, and save all communications with ITS and the clinician.

Product Details

Product: I.T.S. Screw System including cancellous screws, cortical screws, and various washers. Article Numbers include Cannulated cancellous screws: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652

Reported Incidents

No injuries or incidents have been reported.

Key Facts

5,568 units recalled
MRI safety testing identified higher RF-induced heating
Cannulated cancellous screws and cortical screws included
Washer types affected: flat and concave
Nationwide US distribution in AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO,MS
NV, OH, OK, PA, SC, TX, USVI, WV, WA

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

BURNELECTRICAL

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeScrew System for orthopedic implants

Product Details

Jan 23, 2026

I.T.S. GmbH

Updated MRI