What is recalled and why?

I.T.S. GmbH recalls 15,517 FLS Foot Locking Plates System and Hallux Osteotomy Locking Plate devices due to MRI safety concerns. Updated testing shows higher RF heating under specific MRI conditions than stated in the IFU.

What is the immediate risk to patients?

RF heating can raise skin temperature during MRI, potentially causing burns near implanted devices.

What should I do if I own this device?

Stop using the device immediately. Follow recall instructions from the manufacturer and contact I.T.S. GmbH or a healthcare provider for guidance.

Will I get a refund or replacement?

The recall notice does not specify refunds. Follow manufacturer instructions for any remedy.

How can I verify my device is affected?

Cross-check the article numbers on the device packaging or IFU with the list of affected numbers in the recall notice.

Where can I find more information?

Visit the FDA enforcement recall page for Z-1605-2026 and contact I.T.S. GmbH for guidance.

What about MRI scans I need for medical reasons?

Discuss MRI safety with your physician before any scan. The implanted devices can heat under certain MRI conditions.

How long will the recall process take?

Remedies may take several weeks to process by the manufacturer. Expect 4-8 weeks for any replacement or remedy after initiating contact.

What documentation should I keep?

Keep photos of the device, the lot numbers/article numbers, receipts, and all correspondence with the manufacturer.

What rights do I have as a consumer?

You have the right to follow the recall instructions and pursue remedies offered by the manufacturer. If you experience harm or the company is unresponsive, contact appropriate regulatory agencies.

HIGHJanuary 23, 2026

I.T.S. GmbH Recalls 15,517 FLS Foot Locking Plates System and Hallux Osteotomy Plates Over MRI Heat‑

Q: Which models are affected?

Affected article numbers include 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30, 32271-10 to 34, 37304-10 to 24, 21413-6, 21431-ME, 21482, 21483, 21421-5, 37241-10 to 30, 21015-08, 21015-09.

I.T.S. GmbH recalled 15,517 FLS Foot Locking Plates System and HOL Hallux Osteotomy locking plates 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. Patients and healthcare providers should stop using this device immediately and follow the recall instructions from:

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

Foot locking plate systems and hallux osteotomy plates are used to stabilize fractures or correct toe alignment. Surgeons implant these devices during foot surgery.

Why This Is Dangerous

MRI RF heating can cause the implanted device to heat during scans, potentially damaging surrounding tissue.

Industry Context

This recall is not part of a broader industry pattern at this time.

Real-World Impact

Patients may need MRI avoidance or alternate imaging strategies until devices are assessed; healthcare providers may require guidance for imaging planning.

Practical Guidance

How to identify if yours is affected

Check the device packaging and IFU for the article numbers.
Match with the list of affected article numbers provided in the recall notice.
If uncertain, contact the hospital's orthopedic department or I.T.S. GmbH for confirmation.

Where to find product info

Look for the article numbers on the device packaging or IFU; the recall page lists all affected numbers.

What timeline to expect

4-8 weeks for refunds or replacements after initiating contact.

If the manufacturer is unresponsive

Escalate to hospital risk management or patient safety office.
File a report with the FDA recall portal if needed.
Consult legal counsel if there is harm and the company is unresponsive.

How to prevent similar issues

When buying future orthopedic implants, verify MRI compatibility and review the IFU.
Consult your surgeon about MRI risk for implanted devices.
Keep a record of all device identifiers and supplier communications.

Documentation advice

Document all communications, keep serial numbers, and save emails or letters from the manufacturer.

Product Details

Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30; 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34; 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24; 21413-6; 21431-ME; 21482; 21483; 21421-5; 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30; 21015-08, 21015-09. Units recalled: 15,517. Distribution: US nationwide in AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY,LA

Reported Incidents

No injuries or incidents have been reported.

Key Facts

15,517 units recalled
Article numbers span multiple product descriptions
MRI RF heating risk under specific MRI conditions
Status: ACTIVE
US nationwide distribution

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

BURNELECTRICAL

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeFoot Locking Plates System and Hallux Osteotomy Locking Plate

Product Details

Jan 23, 2026

I.T.S. GmbH

Updated MRI