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
- Ulna locking plate system
- Model numbers
- 1. Article Number (Lot Numbers): 21232-3 (26/F65636), 21232-4 (26/F61722, 26/F65637), 21232-6 (26/F62564, 26/F65638), 21233-3 (26/F65639), 21233-4 (26/F65640), 21233-6 (26/F61723 +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 are orthopedic implants used to stabilize the forearm bones during fracture treatment, specifically the distal ulna locking plate system and ulna osteotomy locking system. They may be used with cancellous screws.
Why This Is Dangerous
MRI RF heating can cause temperature rises in the surrounding tissue during scans, potentially leading to burns in patients with these implants.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
The recall requires immediate cessation of use and coordination with clinicians. Impact is primarily on patients with these implants undergoing MRI scans, or considering MRI in the future, and on healthcare providers managing device removals or replacements.
Practical Guidance
How to identify if yours is affected
- 2) Check lot numbers listed in the recall notice (e.g., 26/F65636, etc.).
- 3) If there is a match, stop using the device immediately and inform your healthcare provider.
Where to find product info
Model numbers and lot numbers appear on device packaging and labeling; recall notices from I.T.S. GmbH provide detailed lists.
What timeline to expect
No fixed timeline is provided for replacement or refunds. Manufacturers typically coordinate with hospitals for next steps within weeks to a fewMonths
How to prevent similar issues
- Verify device recalls during preoperative assessments
- Ask surgeons about implant safety and MRI compatibility
- Check for updated IFUs before any MRI procedure
Documentation advice
Keep the recall notice, device model and lot documentation, communications with clinicians, and any MRI reports related to the device.
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Product Details
Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4; 21231-6; 37302-18; 37302-20. Distribution: US nationwide to healthcare providers. Quantity: 120 units. Recall date: 2026-01-23. Country of origin: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- MRI RF-heating risk
- US nationwide distribution to healthcare providers
- No injuries reported
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Safety Guide
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