I.T.S. GmbH recalls foot locking plates systems due to potential MRI safety risks from higher RF-induced 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. GmbH is recalling certain foot locking plates systems because MRI safety testing shows these implants could overheat during MRI scans. This risk is based on updated testing that reveals higher temperature increases than previously reported in the product instructions.
The implants can cause higher temperature increases during MRI scans than previously stated in the product instructions. This is due to the way the metal components interact with MRI's radiofrequency fields, potentially leading to burns if the temperature rises too high.
Patients with these foot locking plates who undergo MRI scans may face overheating risks. The risk is specific to MRI procedures and not general use.
Check if your foot locking plates have the listed article numbers (e.g., 37303-10, 32271-10, etc.) or the corresponding lot numbers provided in the recall notice.
Review the article numbers and lot numbers listed in the recall notice to confirm if your foot locking plates are affected.
No, the recall is specifically for MRI safety. These plates are safe for normal use outside of MRI procedures.
Check the article numbers and lot numbers listed in the recall notice (e.g., 37303-10, 32271-10, etc.) to see if your plates match.
The recall does not mention any remedy or fix. Affected products should be checked for MRI safety before use.
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-1605-2026 — I.T.S. GmbH I.T.S. GmbH Hello, I own a I.T.S. GmbH that is covered by recall Z-1605-2026 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.
