What is the recall about

The recall concerns 623 HCS Headless Cannulated Screws due to MRI RF heating risk. Higher temperature increases during certain MRI conditions could cause injury. Stop use and follow ITS instructions.

Patients undergoing MRI with these implants and the healthcare facilities performing those scans are affected. No injuries have been reported yet.

How do I know if my device is included

Check the article number on the device packaging or labeling. Compare with the listed article numbers in ITS recall communications.

What should I do if I own one

Stop using the device immediately. Contact ITS GmbH or your treating provider for instructions. Follow the official recall notice.

Is there a replacement or refund

The remedy focuses on stopping use and following instructions. Replacement availability or refund details will be provided by ITS GmbH.

Where can I find official information

Refer to the FDA enforcement report for Z-1606-2026 and ITS communications about this recall.

Will MRI be possible with other devices

MRI safety varies by device. Do not MRI any implant unless cleared by a clinician and device manufacturer.

What if MRI was performed recently

Consult your clinician immediately if you had a scan with one of these screws and report any burn-like symptoms.

How is the risk communicated to patients

The recall communicates MRI heating risk and provides steps to discontinue use and seek guidance from the manufacturer.

What documentation should I keep

Retain the packaging, labeling, and any correspondence with ITS GmbH or the medical facility. Photograph labels and article numbers.

What if the company is slow to respond

Document all attempts to contact ITS and consult the FDA recall process for guidance.

HIGHJanuary 23, 2026

ITS GmbH Recalls 623 HCS Headless Cannulated Screws Over MRI Heating Risk (2026)

ITS GmbH recalled 623 HCS Headless Cannulated Screws distributed nationwide to U.S. healthcare facilities. The defect involves higher RF-induced temperature increases during certain MRI procedures than the IFU described. Affected patients and providers should stop using immediately and follow recall instructions. Contact ITS GmbH or your healthcare provider for 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: Unknown
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 HCS Headless Cannulated Screw System is used in orthopedic procedures to fix bone segments. It is designed to be implanted during surgery and remain in the patient.

Why This Is Dangerous

MRI RF heating occurs when radiofrequency energy interacts with the implanted hardware. In this recall, testing showed higher temperature increases than stated in the IFU, creating potential tissue injury risk during MRI.

Industry Context

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

Real-World Impact

The recall affects patients with implanted screws and healthcare facilities performing MRI scans. The immediate action is to stop using the device and follow manufacturer directions to prevent injury.

Practical Guidance

How to identify if yours is affected

1. Locate the article number on the device packaging or labeling.
2. Compare with the list of affected article numbers in ITS communications and FDA notices.
3. If matched, discontinue use.

Where to find product info

FDA enforcement report Z-1606-2026 and ITS recall communications. Manufacturer instructions apply.

What timeline to expect

A recall timeline for replacement, remediation, or refunds will be provided by ITS GmbH. Specific timelines are not published in the available data.

If the manufacturer is unresponsive

Document all attempts to contact ITS GmbH and the treating facility.
Escalate to the FDA recall program if ITS is unresponsive.

How to prevent similar issues

Verify MRI compatibility before scanning any implanted hardware.
Ask surgeons and manufacturers about imaging safety for implants.
Monitor for recall updates from ITS and the FDA.

Documentation advice

Keep all recall notices, labeling, packaging, and correspondence. Document dates of contact and responses from ITS or clinicians.

Product Details

Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90. Distribution: US nationwide to healthcare facilities. Quantity: 623 units. Country of origin: Germany. Note: Some articles include associated lot numbers.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

Recall quantity: 623 units
Article numbers include 31207-10 through 31757-90 (extended list)
US nationwide distribution to healthcare facilities
Hazard: MRI RF heating risk; higher temp increases under certain MRI conditions
No injuries reported to date

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

BURNOTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeHeadless Cannulated Compression Screw System

Product Details

Jan 23, 2026

I.T.S. GmbH

Updated MRI