Is this recall limited to certain MRI machines or all MRI systems?

The recall notice refers to higher RF-induced temperature increases under certain MRI conditions. Consult your healthcare provider and the manufacturer for guidance on specific MRI compatibility.

What should I do if I own one of these devices?

Stop using the device immediately. Contact I.T.S. GmbH for instructions via email and consult your healthcare provider.

Will I get a refund or replacement?

The recall notice directs contacting the manufacturer for instructions. Refund or replacement details are provided by the manufacturer.

Where can I find more information?

See the FDA recall page for Z-1593-2026 and the manufacturer's recall communications.

How many units are involved?

322 units are involved in this recall provided by the notice.

Is the device still allowed to be used in any circumstance?

The recall advises stopping use until guidance is provided by the manufacturer.

MRI procedures could cause higher RF-induced heating of the device, increasing burn risk.

Who issued the recall?

Manufacturer I.T.S. GmbH issued the recall. The notice is active.

What is the status of the recall?

Status is ACTIVE as of the report date in the notice.

HIGHJanuary 23, 2026

I.T.S. GmbH Claviculaplate with Angular Stability Recalled for MRI Heating Risk 322 Units (2026)

Q: Which models are affected?

The affected article numbers include 21116-8, 21117-10, 21118-10, 21121-6, 21121-8, 21122-10, 21122-6, 21122-8, 21123-4, 21124-4, 21127-6, 21128-6.

I.T.S. GmbH recalled 322 Claviculaplate with Angular Stability devices sold nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than the IFU reflected. Healthcare providers and patients should stop using the device immediately and follow recall instructions from the manufacturer.

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, PREGNANT

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 clavicle plates are implants used to stabilize the clavicle after fractures. Hospitals and surgeons typically choose angular stability implants for fracture fixation.

Why This Is Dangerous

MRI exposure can heat the implant more than expected, risking tissue burns to surrounding areas after imaging.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may affect patients currently implanted with the devices and healthcare teams managing scans for these patients.

Practical Guidance

How to identify if yours is affected

Review labeling and recall article numbers listed above
Check the physical plate for the article numbers: 21116-8, 21117-10, 21118-10, 21121-6, 21121-8, 21122-10, 21122-6, 21122-8, 21123-4, 21124-4, 21127-6, 21128-6
If unsure, contact your orthopedic surgeon or hospital's device coordinator

Where to find product info

Article numbers and lot numbers printed on labeling and packaging. FDA recall notice and manufacturer communications

What timeline to expect

4-8 weeks for replacement or instructions, subject to manufacturer processes

If the manufacturer is unresponsive

Document all attempts to contact the manufacturer
Consult hospital compliance or patient advocacy offices
File a complaint with the FDA if the manufacturer fails to respond

How to prevent similar issues

Ask hospitals to confirm which implants are used in any future surgeries
Check MRI compatibility of implants before future imaging
Keep the recall notice with medical records for future reference

Documentation advice

Keep all recall communications, model numbers, lot numbers, and any imaging findings related to MRI scans while implanted

Product Details

Brand: I.T.S. GmbH. Product: Claviculaplate with Angular Stability. Article numbers: 21116-8, 21117-10, 21118-10; 21121-6, 21121-8; 21122-10, 21122-6, 21122-8; 21123-4, 21124-4, 21127-6, 21128-6. Sold nationwide in the United States. Quantity: 322 units. Recall date: 2026-01-23. Status: ACTIVE.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

322 units recalled
Article numbers: 21116-8, 21117-10, 21118-10, 21121-6, 21121-8, 21122-10, 21122-6, 21122-8, 21123-4,
21124-4, 21127-6, 21128-6
Hazard: higher RF-induced heating during MRI under certain conditions
Recall date: 2026-01-23
Status: ACTIVE

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

GENERALPREGNANT

Injury Types

BURN

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeClavicle plate with angular stability (orthopedic implant)

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