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
- Distal Humeral Plate with Angular Stability (Orthopedic Implant)
- Model numbers
- 1. Article Number (Lot Numbers): 37351-10-N (18/240314, 679/122205), 37351-12-N (18/200330, 18/943977, 26/F65544, 679/032401, 679/052417, 679/122261) +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
Distal Humeral Plates with Angular Stability are orthopedic implants used to fix distal humerus fractures. They are installed by surgeons in hospital settings. These devices are intended to remain in the body during the healing process unless removed.
Why This Is Dangerous
MRIs can cause RF heating of implants. In this recall, MRI testing showed higher temperature increases than described in the IFU under certain MRI conditions. This could lead to tissue heating or burns during scanning.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and patients may face MRI delays or appointments being postponed. The recall requires action to prevent potential burns during imaging and to guide decisions about replacement or remediation.
Practical Guidance
How to identify if yours is affected
- Check if your implant article number matches any from 37351-10-N to 37351-85-N or 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
- Review the IFU and recall notice for MRI safety changes.
Where to find product info
Recall notices are available via the FDA enforcement page under recall number Z-1602-2026 and the manufacturer’s communications.
What timeline to expect
Refunds or replacements, if applicable, typically follow a formal recall process. No specific timeline is provided in the available data. Expect 4-8+?
If the manufacturer is unresponsive
- Escalate with the medical facility involved and the manufacturer.
- File a report with FDA if the manufacturer is unresponsive.
- Keep records of all communications and document device details.
How to prevent similar issues
- Before future implants, verify MRI compatibility and updated labeling.
- Ask the surgeon about MRI safety and alternatives if imaging is needed.
- Monitor safety notices for implanted devices and report issues promptly.
Documentation advice
Keep the recall notice, record all model numbers, document communications with providers and the manufacturer, and store medical records related to the device.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution across listed states
- Hazard: MRI RF-induced heating as per updated testing
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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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