What is the HLS Hand Locking Plates System?

The HLS system is a surgical hardware set used in hand reconstruction and fracture repair. It includes plates in multiple shapes and screws for fixation. It is intended for orthopedic surgeon use in operating rooms.

Why was this recall issued?

The recall follows MRI safety testing showing higher RF-induced temperatures with the device under certain MRI conditions than described in the IFU. This could pose a burn risk to patients.

What MRI risk is involved?

Under some MRI sequences and field strengths, the device can heat more than previously reported, raising the potential for tissue burns.

What should I do if I own this device?

Stop using the device immediately. Follow ITS GmbH recall instructions and consult your surgeon or healthcare provider for guidance. Monitor recall updates on the FDA page.

How can I identify if my device is affected?

Check the article numbers listed in the recall for your device or package. Compare with your device labeling and documentation to confirm match.

Where can I get more information?

See the FDA enforcement recall page linked in the notice. Contact ITS GmbH for official guidance.

Will I get a refund or replacement?

ITS GmbH will provide recall-specific remediation. Follow the official instructions for refunds or replacements when available.

What is the recall number?

Recall number Z-1607-2026 is listed on the FDA enforcement page.

Should MRI appointments be canceled or rescheduled?

If you have a device affected by this recall and require MRI, coordinate with your healthcare provider to determine safe alternatives or adjustments.

How long will the recall process take?

The manufacturer has not published a specific remediation timeline. Follow official instructions and monitor updates from ITS GmbH and the FDA.

What should I document?

Save all recall notices, correspondence with ITS GmbH, and any medical records related to the device for future reference.

HIGHJanuary 23, 2026

ITS GmbH HLS Hand Locking Plates System Recalled for MRI Heating Risk (1,307 Units, 2026)

ITS GmbH recalled 1,307 units of the HLS Hand Locking Plates System distributed nationwide in the United States after MRI safety testing showed higher RF-induced temperature increases. The issue exceeds what is described in the IFU under certain MRI conditions. Patients and healthcare providers should stop using the device immediately and follow ITS GmbH'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

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

The HLS Hand Locking Plates System is a modular orthopedic hardware set used to fix and stabilize bones in the hand and digits during reconstructive or fracture procedures.

Why This Is Dangerous

MRI exposure can cause the device to heat more than previously indicated, potentially leading to burns or tissue injury in patients undergoing scanning.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals and patients may need to identify affected implants in inventory. MRI scheduling for affected devices could require adjustment to minimize patient risk and treatment delays.

Practical Guidance

How to identify if yours is affected

Review device labeling for article numbers listed in the recall.
Compare your device’s article numbers to the recalled list.
Consult your surgeon if you are unsure whether your device is affected.

Where to find product info

Article numbers printed on device packaging and IFU. Manufacturer notices and the FDA page also list ranges.

What timeline to expect

Remediation timelines are not published; expect weeks to months for refunds or replacements after verification.

If the manufacturer is unresponsive

Escalate to hospital risk management or patient safety office.
File a formal recall complaint with ITS GmbH and the FDA if needed.

How to prevent similar issues

Verify MRI compatibility before scheduling scans for patients with implanted hardware.
Follow manufacturerCompatibility guidelines and update medical records with device identifiers.
Request replacement plans or alternative imaging protocols if necessary.

Documentation advice

Keep all recall notices, EMR entries, device labels, and communications with ITS GmbH. Document dates and actions taken.

Product Details

Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20; 21505-4, 21506-4; 21507-4, 21508-4; 21517; 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10; 21513-3, 21513-5, 21514-3, 21514-5; 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20. Sold at: Unknown. When sold: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

1,307 units recalled
Distribution nationwide across the United States
MRI RF heating risk confirmed by updated testing
IFU did not reflect higher temperature increases under some MRI conditions
Article numbers span Cortical Screws, HLS Plates, and Locking Stabilization Screws
Notification by email

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

7/ 10

Affected Groups

GENERAL

Injury Types

BURN

Product Classification

CategoryHealth & Personal Care › Orthopedic Medical Devices

Product TypeHand Locking Plates System

Product Details

Jan 23, 2026

I.T.S. GmbH

Updated MRI