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, PREGNANT
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
- Clavicle plate with angular stability (orthopedic implant)
- Model numbers
- 1. Article Number (Lot Numbers): 21116-8 (679/092230), 21117-10 (679/032313, 679/092231), 21118-10 (679/032314, 679/072047, 679/092232). 2. Article Number (Lot Numbers): 21121-6 (679/092236, 679/092329), 21121-8 (679/052226). 3. Article Number (Lot Numbers): 21122-10 (00/0425-02 +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
These clavicle plates are implants used to stabilize the clavicle after fractures. Hospitals and surgeons typically choose angular stability implants for fracture fixation.
Why This Is Dangerous
MRI exposure can heat the implant more than expected, risking tissue burns to surrounding areas after imaging.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may affect patients currently implanted with the devices and healthcare teams managing scans for these patients.
Practical Guidance
How to identify if yours is affected
- Review labeling and recall article numbers listed above
- If unsure, contact your orthopedic surgeon or hospital's device coordinator
Where to find product info
Article numbers and lot numbers printed on labeling and packaging. FDA recall notice and manufacturer communications
What timeline to expect
4-8 weeks for replacement or instructions, subject to manufacturer processes
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer
- Consult hospital compliance or patient advocacy offices
- File a complaint with the FDA if the manufacturer fails to respond
How to prevent similar issues
- Ask hospitals to confirm which implants are used in any future surgeries
- Check MRI compatibility of implants before future imaging
- Keep the recall notice with medical records for future reference
Documentation advice
Keep all recall communications, model numbers, lot numbers, and any imaging findings related to MRI scans while implanted
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Brand: I.T.S. GmbH. Product: Claviculaplate with Angular Stability. Article numbers: 21116-8, 21117-10, 21118-10; 21121-6, 21121-8; 21122-10, 21122-6, 21122-8; 21123-4, 21124-4, 21127-6, 21128-6. Sold nationwide in the United States. Quantity: 322 units. Recall date: 2026-01-23. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Hazard: higher RF-induced heating during MRI under certain conditions
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.