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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- I.T.S. GmbH
- Product type
- Screw System for orthopedic implants
- Model numbers
- 1. Article Number (Lot Numbers): 31404-16 (679/062339, 679/122213, 679/122332), 31404-18 (679/122212, 679/062340), 31404-20 (18/089221, 679/062343, 679/122241) +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 23, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
The I.T.S. Screw System is an orthopedic implant system used in bone fixation. It includes cancellous and cortical screws and washers used in surgical procedures.
Why This Is Dangerous
MRI RF heating can raise temperatures at the implant site, creating a burn risk for patients undergoing MRI under certain conditions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall requires stopping use of affected implants and contacting the manufacturer for guidance, with potential impacts on follow-up imaging and surgical planning.
Practical Guidance
How to identify if yours is affected
- Review the article numbers listed in the recall cover.
- Check the labeling and packaging for article numbers matching the recall list.
- Compare with your implant inventory to identify affected devices.
Where to find product info
Article numbers appear on device packaging, labeling, or surgical documentation.
What timeline to expect
Remedy processing may take 4-6 weeks, depending on inventory and manufacturer actions.
If the manufacturer is unresponsive
- Document all attempts to contact ITS and your clinician.
- Escalate to hospital risk management or patient safety officials if the company is slow to respond.
How to prevent similar issues
- Before surgery, confirm MRI compatibility of implants with the surgeon.
- Ask for updated safety instructions if MRI is anticipated for a patient with implants.
- Keep the recall documentation with patient records for future reference.
Documentation advice
Keep a copy of the recall notice, record all article numbers checked, and save all communications with ITS and the clinician.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- MRI safety testing identified higher RF-induced heating
- Cannulated cancellous screws and cortical screws included
- Washer types affected: flat and concave
- Nationwide US distribution in AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO,MS
- NV, OH, OK, PA, SC, TX, USVI, WV, WA
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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