Quick Facts at a Glance
- Recall Date
- January 23, 2026
- Hazard Level
- HIGH
- Brand
- I.T.S. GmbH
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Proximal Humeral Plate (Humeral Head Plate)
- Model numbers
- Article Number (Lot Numbers): 211341-10 (26/F63368, 26/F65625, 26/F66904, 26/F669041, 679/012410), 211341-4 (26/F63366, 26/F65626, 26/F656261 +12 more
- Sold at
- Multiple Retailers
- 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 Humeral Head Plate is used to fix proximal humerus fractures. It is implanted during surgery and intended to support bone healing.
Why This Is Dangerous
MRI exposure can cause RF-induced heating of the implanted plate. Elevated temperatures risk tissue damage or burns around the implant site under certain MRI conditions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients with this implant may be limited in MRI access or require medical follow-up. The recall could lead to imaging delays and potential additional surgeries if MRI is needed.
Practical Guidance
How to identify if yours is affected
- Review packaging or medical records for the article number.
- Consult your surgeon or healthcare provider for next steps.
Where to find product info
Official recall notices and the FDA enforcement page list affected article numbers and guidance.
What timeline to expect
No specific timeframe for replacement or refund is provided in the recall notice.
If the manufacturer is unresponsive
- Document every contact with the manufacturer.
- File a complaint with the appropriate medical device regulator if the manufacturer is unresponsive.
- Consult legal counsel if needed for patient rights.
How to prevent similar issues
- When planning implants, verify MRI safety information and imaging compatibility.
- Ask surgeons about MRI planning for patients with implants.
- Keep track of device documentation and recall updates for future implants.
Documentation advice
Keep the recall notice, your implant article numbers, medical records, and communications with the manufacturer for your records.
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Product Details
Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4. Distribution: US nationwide in AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W. Sold at: Not specified. Price: Not specified.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distribution: US nationwide (AL, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT,
- NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W)
- Hazard: MRI heating risk during MRI
- Remedy: Stop using and contact ITS GmbH/healthcare provider for instructions
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Safety Guide
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