What is being recalled?

ITS GmbH recalls 292 proximal humeral plates due to MRI heating risk. The recall covers multiple article numbers associated with the device. Users should stop using the device and follow the recall instructions.

Are there any reported injuries?

No injuries or incidents have been reported to date.

What should patients do now?

Stop using the device and follow the recall instructions. Contact ITS GmbH or your healthcare provider for guidance.

How can I check if my implant is affected?

Review the article numbers listed above on any packaging or documentation associated with the implant. Compare with your device to determine if it is affected.

Will MRI be safe for affected patients?

MRI should not be performed with this device until clearance is provided by a clinician or manufacturer. Follow the recall instructions for imaging guidance.

How do I get a refund or replacement?

The recall notice does not specify a refund program. Follow official recall instructions for next steps.

Where can I find the official recall notice?

Refer to the FDA enforcement page for Z-1594-2026 and the manufacturer’s recall communications.

What if I have an urgent medical concern?

Contact your healthcare provider immediately for medical advice. If you experience complications, seek urgent care.

Will there be ongoing monitoring or updates?

Manufacturers and regulators may issue updates if safety data changes. Monitor official recall notices and FDA communications for new guidance.

What should I document?

Keep the recall notice, device serial/article numbers, communications with the manufacturer, and any imaging-related instructions provided by clinicians.

HIGHJanuary 23, 2026

ITS GmbH Humeral Head Plate MRI Recall Affects 292 Units in 2026

Q: Why is this recall issued?

Updated MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions than previously reflected in the IFU. This could lead to tissue damage or burns.

Q: Which models are affected?

Affected article numbers include 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.

ITS GmbH recalled 292 proximal humeral plates nationwide in the United States after MRI safety testing showed higher RF-induced heating under certain MRI conditions. The heating can occur during MRI and may cause burns or tissue damage. Patients and clinicians should stop using the device immediately and follow the recall instructions from ITS GmbH and their healthcare providers.

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 Humeral Head Plate is used to fix proximal humerus fractures. It is implanted during surgery and intended to support bone healing.

Why This Is Dangerous

MRI exposure can cause RF-induced heating of the implanted plate. Elevated temperatures risk tissue damage or burns around the implant site under certain MRI conditions.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients with this implant may be limited in MRI access or require medical follow-up. The recall could lead to imaging delays and potential additional surgeries if MRI is needed.

Practical Guidance

How to identify if yours is affected

Check if your implant article number matches any of the listed models (211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4).
Review packaging or medical records for the article number.
Consult your surgeon or healthcare provider for next steps.

Where to find product info

Official recall notices and the FDA enforcement page list affected article numbers and guidance.

What timeline to expect

No specific timeframe for replacement or refund is provided in the recall notice.

If the manufacturer is unresponsive

Document every contact with the manufacturer.
File a complaint with the appropriate medical device regulator if the manufacturer is unresponsive.
Consult legal counsel if needed for patient rights.

How to prevent similar issues

When planning implants, verify MRI safety information and imaging compatibility.
Ask surgeons about MRI planning for patients with implants.
Keep track of device documentation and recall updates for future implants.

Documentation advice

Keep the recall notice, your implant article numbers, medical records, and communications with the manufacturer for your records.

Product Details

Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4. Distribution: US nationwide in AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W. Sold at: Not specified. Price: Not specified.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

292 units recalled
Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7
Distribution: US nationwide (AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT,
NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W)
Hazard: MRI heating risk during MRI
Remedy: Stop using and contact ITS GmbH/healthcare provider for instructions

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

BURN

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeProximal Humeral Plate (Humeral Head Plate)

Product Details

Brand

I.T.S. GmbH

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