I.T.S. recalls certain Humeral Head Plates with Angular Stability due to potential MRI safety risks. Updated MRI testing shows higher RF temperature increases than previously stated in instructions.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. is recalling specific models of Humeral Head Plates with Angular Stability because MRI safety testing shows they could cause higher temperature increases during MRI scans than previously reported. This could lead to burns or other injuries if used in MRI environments.
These plates can cause higher RF-induced temperature increases during MRI scans than previously stated in the product instructions. This risk could lead to burns or other injuries if the device is used in MRI environments without proper safety checks.
Patients using these plates for joint replacement surgery are most at risk if they undergo MRI scans. The recall affects specific model numbers and lot numbers listed in the official notice.
Check for model 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. Also check the lot numbers listed in the recall notice.
Review the model and lot numbers on your device to see if it matches the recalled items listed in the notice.
No, but you should check if your device is recalled before undergoing any MRI scans.
Check the model and lot numbers against the list provided in the recall notice to determine if it's affected.
The risk is that higher RF temperature increases during MRI scans could cause burns, but the device is safe for use outside MRI environments.
We’ve drafted a message you can send I.T.S. GmbH to request your refund or repair — edit it as you like.
Subject: Recall Z-1594-2026 — I.T.S. GmbH I.T.S. GmbH Hello, I own a I.T.S. GmbH that is covered by recall Z-1594-2026 from I.T.S. GmbH. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
