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
- Fibula Plate PROlock with Angular Stability
- Model numbers
- 1. Article Number (Lot Numbers): 21602-3 (643/072330, 643/092310), 21602-4 (643/072301, 643/072308), 21602-5 (643/022417, 643/0650, 643/072309), 21602-6 (643/042305 +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
This is an orthopedic implant used to stabilize fibula fractures. It is implanted surgically and remains in the patient after recovery.
Why This Is Dangerous
MRI exposure can cause RF-induced heating at the implant site. This heating may injure surrounding tissue during scans under certain conditions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects patients with these implants and hospitals performing MRIs. Imaging decisions may change and patients may need follow-up planning.
Practical Guidance
How to identify if yours is affected
- Identify if your implant is one of the ITS Fibula Plate PROlock with Angular Stability article numbers listed in the recall.
- Check with your surgeon or implant center to confirm the device model and MRI compatibility.
- Review the FDA recall page for current instructions.
Where to find product info
Look in your surgical records, implant documentation, and the recall notice. The FDA enforcement page lists all affected article numbers.
What timeline to expect
Actions by hospitals may occur within weeks to months. Individual timelines depend on clinical circumstances and manufacturer guidance.
If the manufacturer is unresponsive
- Escalate to the hospital's medical device coordinator.
- Contact the recall sponsor and report lack of response to the appropriate regulatory body if needed.
How to prevent similar issues
- Before MRI, verify implant compatibility with MRI settings.
- Ask about MRI sequences and specific absorption rates when implants are present.
- Ask facilities to use implants with proven MRI compatibility for future devices.
Documentation advice
Keep copies of recall notices, communication with providers, and imaging decisions. Record dates, names, and actions taken.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 869 total units recalled
- Distribution: United States nationwide across listed states
- Hazard: higher RF-induced heating during MRI under certain conditions
- Status: ACTIVE recall as of 2026-04-01
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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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