What is the recall number for this issue?

The recall is identified as Z-1602-2026 in the FDA enforcement reporting system.

What products are affected by this recall?

Distal Humeral Plates with Angular Stability with article numbers 37351-10-N through 37351-85-N, and the Humeral Plate, Distal series 21241-5, 21241-7, 21242-7, 21243-10, and 21244-9.

Who is affected by this recall?

Patients and healthcare providers using these implants in the United States.

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

Stop using the device immediately and follow the manufacturer’s recall instructions. Contact I.T.S. GmbH or your healthcare provider for guidance.

Should I still have an MRI if I have one of these implants?

Do not undergo MRI with this device until a medical professional advises it is safe under updated labeling.

How many units are recalled?

12,059 units are affected by this recall in the United States.

Where can I find more information about the recall?

Details are posted on the FDA enforcement page for Z-1602-2026 and the manufacturer’s recall communications.

How will I know if my device is affected?

Check the article numbers listed above on your implant and consult your healthcare provider for verification.

Will I receive a refund or replacement?

The recall directs patients to follow manufacturer instructions for next steps. Contact I.T.S. GmbH for guidance on potential replacement or remediation.

What should I do if the manufacturer is slow to respond?

Document all communications, contact your healthcare provider for interim guidance, and consider reporting to FDA if there is no timely response.

Is this recall part of a broader industry pattern?

The notice indicates this is an updated MRI safety issue specific to these devices and is not described as a broader pattern.

HIGHJanuary 23, 2026

I.T.S. GmbH Distal Humeral Plates Recalled for MRI Heating Risk — 12,059 Units (2026)

I.T.S. GmbH recalled 12,059 Distal Humeral Plates with Angular Stability due to MRI heating risk. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than reflected in the IFU. Healthcare providers and patients should stop using the device and follow 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: 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

Distal Humeral Plates with Angular Stability are orthopedic implants used to fix distal humerus fractures. They are installed by surgeons in hospital settings. These devices are intended to remain in the body during the healing process unless removed.

Why This Is Dangerous

MRIs can cause RF heating of implants. In this recall, MRI testing showed higher temperature increases than described in the IFU under certain MRI conditions. This could lead to tissue heating or burns during scanning.

Industry Context

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

Real-World Impact

Hospitals and patients may face MRI delays or appointments being postponed. The recall requires action to prevent potential burns during imaging and to guide decisions about replacement or remediation.

Practical Guidance

How to identify if yours is affected

Check if your implant article number matches any from 37351-10-N to 37351-85-N or 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
Review the IFU and recall notice for MRI safety changes.
Confirm whether your device was distributed in your state (AL, AZ, BVI, 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).

Where to find product info

Recall notices are available via the FDA enforcement page under recall number Z-1602-2026 and the manufacturer’s communications.

What timeline to expect

Refunds or replacements, if applicable, typically follow a formal recall process. No specific timeline is provided in the available data. Expect 4-8+?

If the manufacturer is unresponsive

Escalate with the medical facility involved and the manufacturer.
File a report with FDA if the manufacturer is unresponsive.
Keep records of all communications and document device details.

How to prevent similar issues

Before future implants, verify MRI compatibility and updated labeling.
Ask the surgeon about MRI safety and alternatives if imaging is needed.
Monitor safety notices for implanted devices and report issues promptly.

Documentation advice

Keep the recall notice, record all model numbers, document communications with providers and the manufacturer, and store medical records related to the device.

Product Details

Product: Distal Humeral Plates with Angular Stability. Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. Humeral Plate, Distal: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9. Quantity: 12,059 units. Distribution: US nationwide in AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO,

Reported Incidents

No injuries or incidents have been reported.

Key Facts

12,059 units recalled
Article numbers include 37351-10-N to 37351-85-N and 21241-5, 21241-7, 21242-7, 21243-10, 21244-9
US nationwide distribution across listed states
Recall date 2026-01-23
Status: ACTIVE
Hazard: MRI RF-induced heating as per updated testing

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

BURN

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeDistal Humeral Plate with Angular Stability (Orthopedic Implant)

Product Details

Jan 23, 2026

I.T.S. GmbH

Updated MRI