What is being recalled?

The FR.O.H. Calcaneus Repair System, Anterolateral Calcaneus Plate, Article 21064-60, distributed in the US, is recalled due to MRI heating risk.

Who is affected by this recall?

Patients and healthcare providers using the device in the United States are affected.

What should I do if I own this device?

Stop using the device and follow the manufacturer’s recall instructions. Contact your healthcare provider for guidance.

How many units are recalled?

Four units are included in the recall."},{"q":"What should I do about MRI procedures?","a":"Do not use this device for MRI until advised by your healthcare provider and the manufacturer.

How can I get more information?

Refer to the FDA recall page for Z-1595-2026 and the manufacturer’s recall notice emailed to providers."},{"q":"Will I receive a replacement or refund?","a":"Remedies will be provided per the manufacturer’s recall instructions. Contact I.T.S. GmbH for details."},{"q":"Is there a risk of injury now?","a":"There are no reported injuries or incidents to date, but the potential for MRI-related heating exists under certain conditions."},{"q":"Where was the device distributed?","a":"US nationwide, in多

How long will the remedy take?

Remedy timelines vary; recall processing typically follows manufacturer guidance and regulatory coordination.

Where can I find the official recall notice?

The recall is listed on the FDA enforcement page with recall number Z-1595-2026.

Should I remove implanted devices before MRI scans?

Consult your healthcare provider before any MRI or related imaging if you have the implant.

What records should I keep?

Keep the recall notice, any emails from the manufacturer, and notes of communications with your provider.

HIGHJanuary 23, 2026

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

Q: Why is this recall issued?

Updated MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions than described in the IFU.

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.

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 FR.O.H. Calcaneus Repair System is an orthopedic implant used to fix calcaneus (heel bone) fractures. The Anterolateral Calcaneus Plate is part of a stabilization system used by surgeons in complex fracture repairs.

Why This Is Dangerous

MRI scans on patients with the implant may experience higher RF-induced heating under specific MRI conditions. This heating could potentially injure surrounding tissue if not addressed.

Industry Context

This recall is not described as part of a broader industry pattern; it relates specifically to MRI safety testing updates for this device.

Real-World Impact

The risk is limited to MRI procedures involving the implant. The recall requires immediate discontinuation of use and coordination with the manufacturer for safe handling or replacement.

Practical Guidance

How to identify if yours is affected

Confirm you have FR.O.H. Calcaneus Repair System, Anterolateral Calcaneus Plate Article 21064-60
Check associated lot numbers 679/012318 or 679/0722100
Verify the device was distributed in the US
Locate manufacturer recall notification email
Consult with your healthcare provider for next steps

Where to find product info

Refer to the recall notice email and the FDA enforcement page for Z-1595-2026

What timeline to expect

Remedy processing timelines are determined by the manufacturer and health regulatory coordination; typically weeks to months

If the manufacturer is unresponsive

Document all contact attempts with the manufacturer
Escalate to your hospital risk management or patient safety office
File a report with the FDA if no action is taken in a reasonable period

How to prevent similar issues

For future implants, verify MRI safety compatibility and check for recall notices before use
Request updated IFUs and MRI guidelines from surgeons or manufacturers
Maintain a personal record of all implant device IDs and lot numbers

Documentation advice

Keep all recall notices, emails, and correspondence with healthcare providers and the manufacturer. Photograph labels and packaging if possible.

Product Details

Product: FR.O.H. Calcaneus Repair System, Anterolateral Calcaneus Plate Article Number: 21064-60 Lot Numbers: 679/012318, 679/0722100 Sold in: United States nationwide (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) Recall Date: 2026-01-23 Quantity Recalled: 4 Manufacturer: I.T.S. GmbH Price: Unknown Sold Through: Healthcare providers and distribution channels in the US (not consumer retail)

Reported Incidents

No injuries or incidents have been reported.

Key Facts

Article Number 21064-60
Lot Numbers 679/012318 and 679/0722100
4 units recalled
US nationwide distribution (states listed)
Recall date 2026-01-23
No injuries reported

View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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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 TypeAnterolateral Calcaneus Plate

Product Details

Jan 23, 2026

I.T.S. GmbH

Updated MRI