Is my ITS pelvic reconstruction system recalled?

Yes. The recall covers a broad set of ITS pelvic reconstruction implants and components listed by article numbers. Check your device labeling and the recall notice to confirm if your specific article number is included.

Which article numbers are affected?

The recall lists many article numbers across plates and screws, including 21218-16, 21219-16, 21218-14, 21219-14, 21216-10, 21216-12, 21217-10, 21217-12, and hundreds more. Review the official recall for the full list.

What should I do if I have surgery planned?

Do not undergo MRI using this device unless cleared by your physician. Notify your radiology and surgical team about the recall and MRI heating risk.

Will I receive a refund or replacement?

Refunds or replacements will be handled under the manufacturer recall process. Follow the recall instructions and contact ITS for eligibility details.

How do I contact ITS for relief?

Refer to the official recall notice and FDA enforcement page for the contact method. If you cannot locate it, ask your healthcare provider for guidance.

Is this recall limited to the United States?

Yes. The recall specifies US nationwide distribution in multiple states.

Are there symptoms patients should watch for?

The recall concerns MRI heating risk rather than immediate post-implant symptoms. Patients should avoid MRI until cleared and inform clinicians about the recall.

Does this recall affect imaging in any way other than temperature rises?

The notice focuses on RF-induced heating in MRI. Other imaging modalities are not specified as affected.

What if I already underwent MRI with these devices?

Contact your physician promptly to assess any potential risk. The recall guidance emphasizes stopping MRI use under the specified conditions.

What should I document for records?

Retain recall notices, device article numbers, MRI history, and all communications with providers and ITS for refund or replacement.

Where can I find the recall notification details?

The FDA enforcement tab referenced in the recall provides official details and instructions. Check the linked recall page.

HIGHJanuary 23, 2026

I.T.S. Pelvic Reconstruction System Recall for MRI Heating Risk (46,637 Units) 2026

I.T.S. recalled 46,637 pelvic reconstruction system components nationwide in the United States after MRI safety testing showed higher RF-induced heating than the IFU stated. The issue centers on MRI heating under certain conditions that could injure patients. Patients should stop using the devices and follow manufacturer 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 ITS Pelvic Reconstruction System is a modular orthopedic implant set used to treat pelvic fractures and reconstruct pelvic anatomy. It includes plates, screws, and related fixation components. Surgeons select specific configurations based on fracture pattern and anatomy.

Why This Is Dangerous

MRI exposure can cause RF-induced heating of implanted hardware. Under certain MRI conditions, the temperature rise may be higher than the IFU describes, creating a risk to surrounding tissue.

Industry Context

This recall is not described as part of a broader industry pattern in the provided notice.

Real-World Impact

The recall could disrupt planned surgeries or follow-up MRIs. Patients with the device should avoid MRI until cleared and coordinate with their healthcare team for refunds or replacements.

Practical Guidance

How to identify if yours is affected

Review device labeling for article numbers listed in the recall.
Compare your implant components to the article numbers in the recall summary.
Check packaging and IFU for MRI safety specifications.

Where to find product info

Identifiers are located on device labeling and packaging. Article numbers appear in the IFU and the recall listing. The FDA recall page provides the official dataset.

What timeline to expect

Not specified in the recall; refunds or replacements will be issued per ITS instructions and may require coordination with healthcare providers.

If the manufacturer is unresponsive

Escalate to your hospital’s risk management or patient safety office.
Consider filing a complaint with the FDA if there is delayed resolution.
Consult a medical attorney if you experience complications or the vendor is unresponsive.

How to prevent similar issues

Verify MRI compatibility and safety with implanted devices before scheduling scans.
Ask surgeons and radiologists to confirm MRI protocol compatibility with the specific implant.
Keep up to date with manufacturer recalls and product alerts.

Documentation advice

Keep copies of recall notices, labeling, article numbers, MRI history, and all correspondence with ITS and healthcare providers.

Product Details

Product family: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix). 46,637 units recalled. Nationwide US distribution. Article numbers include numerous plate and screw components as listed in the recall summary.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

46,637 units recalled nationwide in the US
Multiple device families affected including Anterior/Posterior Column Plates, Quadrilateral Buttress
RF-induced heating risk during MRI under certain conditions
No injuries or incidents reported to date
Follow recall instructions for refunds or replacements

View Original Recall on FDA - Medical Devices

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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

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Safety Assessment

Risk LevelHIGH

Severity Score

7/ 10

Affected Groups

GENERAL

Injury Types

ELECTRICAL

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypePelvic Reconstruction System implants and components

Product Details

Jan 23, 2026

I.T.S. GmbH

Updated MRI