Quick Facts at a Glance
- Recall Date
- January 23, 2026
- Hazard Level
- HIGH
- Brand
- I.T.S. GmbH
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Headless Cannulated Compression Screw System
- Model numbers
- Article Number (Lot Numbers): 31207-10 (679/112002), 31207-12 (679/092133, 679/102343, 679/112006), 31207-14 (679/102050), 31207-16 (679/102345, 679/102049), 31207-18 (679/0323110 +12 more
- Sold at
- Unknown
- 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 HCS Headless Cannulated Screw System is used in orthopedic procedures to fix bone segments. It is designed to be implanted during surgery and remain in the patient.
Why This Is Dangerous
MRI RF heating occurs when radiofrequency energy interacts with the implanted hardware. In this recall, testing showed higher temperature increases than stated in the IFU, creating potential tissue injury risk during MRI.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall affects patients with implanted screws and healthcare facilities performing MRI scans. The immediate action is to stop using the device and follow manufacturer directions to prevent injury.
Practical Guidance
How to identify if yours is affected
- 1. Locate the article number on the device packaging or labeling.
- 2. Compare with the list of affected article numbers in ITS communications and FDA notices.
- 3. If matched, discontinue use.
Where to find product info
FDA enforcement report Z-1606-2026 and ITS recall communications. Manufacturer instructions apply.
What timeline to expect
A recall timeline for replacement, remediation, or refunds will be provided by ITS GmbH. Specific timelines are not published in the available data.
If the manufacturer is unresponsive
- Document all attempts to contact ITS GmbH and the treating facility.
- Escalate to the FDA recall program if ITS is unresponsive.
How to prevent similar issues
- Verify MRI compatibility before scanning any implanted hardware.
- Ask surgeons and manufacturers about imaging safety for implants.
- Monitor for recall updates from ITS and the FDA.
Documentation advice
Keep all recall notices, labeling, packaging, and correspondence. Document dates of contact and responses from ITS or clinicians.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Recall quantity: 623 units
- Article numbers include 31207-10 through 31757-90 (extended list)
- US nationwide distribution to healthcare facilities
- Hazard: MRI RF heating risk; higher temp increases under certain MRI conditions
- No injuries reported to date
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.