HIGH

I.T.S. Volar Radius Plate PROlock II Recall 220 Units for MRI Heating Risk (2026)

I.T.S. GmbH recalled 220 Volar Radius Plate PROlock II devices after updated MRI safety testing showed higher RF-induced temperatures under certain MRI conditions. The devices were distributed nationwide in the United States. Clinicians and patients should stop using the device immediately and follow the 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

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 Volar Radius Plate PROlock II is used to fix distal radius fractures. It provides angular stability for fracture fixation in surgical procedures.

Why This Is Dangerous

MRI exposure may cause higher RF-induced heating in the presence of the device under certain scanner conditions. That heating could pose a risk to surrounding tissue.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Clinicians and patients may need to modify MRI plans or remove/replace the device to ensure patient safety. No injuries have been reported to date, but the risk warrants precaution.

Practical Guidance

How to identify if yours is affected

  1. Check the device labeling for article numbers 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3
  2. Compare with listed lot numbers if available
  3. Consult your healthcare provider or ITS for confirmation

Where to find product info

Labeling on the implant packaging and the Instructions for Use; manufacturer recall notice; ITS website or patient communications

What timeline to expect

Recall resolution or replacement instructions typically take 4-6 weeks, subject to manufacturer logistics

If the manufacturer is unresponsive

  • Escalate to healthcare providers for interim guidance
  • Contact the FDA recall program if you cannot reach the manufacturer
  • Keep all records of communication

How to prevent similar issues

  • Verify MRI compatibility for implants before imaging
  • Ask for MRI safety documentation when selecting implants
  • Maintain an updated registry of implanted devices for patients and clinicians

Documentation advice

Retain recall notices, take photos of device labeling, document dates of communication with providers and manufacturers

Product Details

Product: Volar Radius Plate with Angular Stability, PROlock II Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3 and related lot numbers Quantity: 220 units Distribution: US Nationwide (AL, AZ, 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) Sold At: Multiple Retailers Recall Date: 2026-01-23 Status: Active Hazard: Higher RF-induced temperature increases during MRI under certain conditions beyond what is described in the IFU Remedy: Stop using the device and follow

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Quantity recalled: 220 units
  • Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 2
  • Distribution: US nationwide in many states
  • Recall date: 2026-01-23
  • Hazard: MRI heating risk during scans
  • Status: Active
View Original Recall on FDA - Medical Devices

Browse More Recalls

More from FDA_DEVICEHealth & Personal CareMedical Devices

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
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeVolar Radius Plate PROlock II
Sold At
Multiple Retailers

Product Details

Model Numbers
Article Number (Lot Numbers): 21031-3 (679/042207
679/032240
679/0323115
679/052317
26/F70606
+8 more
Affected States
ALL
Report Date
April 1, 2026
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

I.T.S. Screw System Recalled for MRI Heating Risk in 5,568 Units (2026)

I.T.S. GmbH has recalled 5,568 units of the I.T.S. Screw System sold nationwide in the United States after MRI safety tests showed higher RF-induced temperature increases under some MRI conditions than the IFU outlined. The defect involves MRI RF heating that could burn patients. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH

ITS GmbH Recalled 510 I.T.S Straight Plate with Angular Stability Over MRI Heating Risk (2026)

ITS GmbH recalled 510 units of the I.T.S Straight Plate with Angular Stability after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions. The recall covers multiple article numbers across forearm and straight plates and distributions nationwide in the United States. No injuries or incidents have been reported at this time. Healthcare providers andpatients

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH

I.T.S. GmbH LRS Orthopedic System Recall: 176 Units for MRI Heating Risk (2026)

ITS GmbH recalled 176 units nationwide in the United States after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions. The issue could cause burns during MRI exposure. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH

ITS GmbH Recalled 11 Pelvic Reconstruction System PRS Components for MRI Heating Risk (2026)

ITS GmbH recalled 11 Pelvic Reconstruction System PRS components after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions than described in the IFU. The recall covers Fixation Screw 70312 and Spike short 70314. Healthcare providers and patients should stop using the devices and follow the manufacturer’s recall instructions provided by email.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH

ITS GmbH Pilon Plate with Angular Stability Recalled for MRI Heating Risk (2026) 101 Units

ITS GmbH recalls 101 Pilon Plate with Angular Stability implants 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. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH

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

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.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH

ITS Fibula Plate PROlock with Angular Stability Recall Affects 869 Units (2026)

ITS recalls 869 Fibula Plate PROlock with Angular Stability implants 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. Hospitals and healthcare providers should stop using this device immediately and follow the recall instructions.

I.T.S. GmbH
Updated MRI
Read more
Health & Personal Care
HIGH

I.T.S. GmbH Claviculaplate with Angular Stability Recalled for MRI Heating Risk 322 Units (2026)

I.T.S. GmbH recalled 322 Claviculaplate with Angular Stability devices sold nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than the IFU reflected. Healthcare providers and patients should stop using the device immediately and follow recall instructions from the manufacturer.

I.T.S. GmbH
Updated MRI
Read more