Is my I.T.S. DUL or UOL system affected by this recall?

Check the article numbers listed in the recall. If your device matches any listed model numbers (for example 21232-3, 21231-6, 37302-18, 37302-20, etc.), you should stop using the device and follow the recall instructions.

Have there been injuries reported from this recall?

No injuries or incidents have been reported to date.

What should I do if I recently had an MRI with this device?

If you had an MRI and your device is one of the listed models, contact your healthcare provider immediately for guidance and possible evaluation.

How do I identify if my device is affected?

Identify the model number on the device packaging or labeling and compare it to the listed article numbers in the recall notice.

Where can I get more information?

Refer to the recall notice page and contact the manufacturer or your healthcare provider for instructions.

Will I receive a replacement or refund?

The recall advises stopping use and following manufacturer instructions. Specific replacement or refund details will be provided by the manufacturer.

How long will the resolution take?

The recall notice does not specify an exact timeline. Processing typically depends on manufacturer guidance and clinical coordination.

Should I avoid MRI scans if I have this device?

Yes. Do not undergo MRI until your clinician clears it in light of the recall.

What steps should I take to document this recall?

Keep the recall notice, record device model and lot numbers, and document communications with your surgeon or device coordinator.

Who should I contact for assistance?

Contact your healthcare provider or the manufacturer via the recall notice for instructions.

Is this recall part of a broader industry pattern?

The recall notes this as an updated MRI safety concern for these specific devices and does not indicate a broader industry pattern.

HIGHJanuary 23, 2026

I.T.S. Ulna Locking Plate Systems Recalled Over MRI Heating Risk (2026)

I.T.S. GmbH recalled 120 units of its DUL and UOL ulna locking plate systems distributed nationwide to U.S. healthcare providers after MRI safety testing showed higher RF-induced heating. The updated testing found temperature increases under certain MRI conditions not reflected in the Instructions for Use. Healthcare facilities and patients should stop using the devices immediately and follow the厂

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

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

These are orthopedic implants used to stabilize the forearm bones during fracture treatment, specifically the distal ulna locking plate system and ulna osteotomy locking system. They may be used with cancellous screws.

Why This Is Dangerous

MRI RF heating can cause temperature rises in the surrounding tissue during scans, potentially leading to burns in patients with these implants.

Industry Context

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

Real-World Impact

The recall requires immediate cessation of use and coordination with clinicians. Impact is primarily on patients with these implants undergoing MRI scans, or considering MRI in the future, and on healthcare providers managing device removals or replacements.

Practical Guidance

How to identify if yours is affected

1) Locate the device model number on packaging or labeling to see if it matches any of 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4, 21231-6, 37302-18, or 37302-20.
2) Check lot numbers listed in the recall notice (e.g., 26/F65636, etc.).
3) If there is a match, stop using the device immediately and inform your healthcare provider.

Where to find product info

Model numbers and lot numbers appear on device packaging and labeling; recall notices from I.T.S. GmbH provide detailed lists.

What timeline to expect

No fixed timeline is provided for replacement or refunds. Manufacturers typically coordinate with hospitals for next steps within weeks to a fewMonths

If the manufacturer is unresponsive

1) Escalate with your hospital's OR manager or device coordinator. 2) File a complaint with the hospital’s risk management. 3) Contact the manufacturer using the recall notice for escalation.
preventionTips [

How to prevent similar issues

Verify device recalls during preoperative assessments
Ask surgeons about implant safety and MRI compatibility
Check for updated IFUs before any MRI procedure

Documentation advice

Keep the recall notice, device model and lot documentation, communications with clinicians, and any MRI reports related to the device.

Product Details

Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4; 21231-6; 37302-18; 37302-20. Distribution: US nationwide to healthcare providers. Quantity: 120 units. Recall date: 2026-01-23. Country of origin: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

120 units recalled
MRI RF-heating risk
Article numbers 21232-3 to 21235-4, 21231-6, 37302-18, 37302-20
US nationwide distribution to healthcare providers
Recall date 2026-01-23
No injuries reported

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

GENERAL

Injury Types

BURN

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeUlna locking plate system

Product Details

Brand

I.T.S. GmbH

Related Recalls

Health & Personal Care

HIGH

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

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.

Jan 23, 2026

I.T.S. GmbH

Updated MRI

Health & Personal Care

HIGH

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

Jan 23, 2026

I.T.S. GmbH

Updated MRI

Health & Personal Care

HIGH

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.

Jan 23, 2026

I.T.S. GmbH

Updated MRI

Health & Personal Care

HIGH

I.T.S. Volar Radius Plate PROlock II Recall 220 Units for MRI Heating Risk (2026)

I.T.S. GmbH recalled 220 Volar Radius Plate PROlock II devices after updated MRI safety testing showed higher RF-induced temperatures under certain MRI conditions. The devices were distributed nationwide in the United States. Clinicians and patients should stop using the device immediately and follow the manufacturer recall instructions.

Jan 23, 2026

I.T.S. GmbH

Updated MRI

Health & Personal Care

HIGH

ITS GmbH Recalled 11 Pelvic Reconstruction System PRS Components for MRI Heating Risk (2026)

ITS GmbH recalled 11 Pelvic Reconstruction System PRS components after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions than described in the IFU. The recall covers Fixation Screw 70312 and Spike short 70314. Healthcare providers and patients should stop using the devices and follow the manufacturer’s recall instructions provided by email.

Jan 23, 2026

I.T.S. GmbH

Updated MRI

Health & Personal Care

HIGH

ITS GmbH Pilon Plate with Angular Stability Recalled for MRI Heating Risk (2026) 101 Units

ITS GmbH recalls 101 Pilon Plate with Angular Stability implants distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

Jan 23, 2026

I.T.S. GmbH

Updated MRI

Health & Personal Care

HIGH

I.T.S. FR.O.H. Calcaneus Plate Recalled for MRI Heating Risk in 4 Units (2026)

I.T.S. GmbH is recalling the FR.O.H. Calcaneus Repair System, Anterolateral Calcaneus Plate, 4 units, distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

Jan 23, 2026

I.T.S. GmbH

Updated MRI

Health & Personal Care

HIGH

ITS Fibula Plate PROlock with Angular Stability Recall Affects 869 Units (2026)

ITS recalls 869 Fibula Plate PROlock with Angular Stability implants distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than previously reflected in the IFU. Hospitals and healthcare providers should stop using this device immediately and follow the recall instructions.

Jan 23, 2026

I.T.S. GmbH

Updated MRI